Salmonella Infections
Conditions
Brief summary
The purpose of this study is to assess the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid conjugate (iNTS-TCV) candidate vaccine to be administered for the first time in humans. The study intervention will be evaluated in European adults in Stage 1 (a 2-step staggered design) followed by African adults in Stage 2.
Interventions
BIOLOGICALInvasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) full dose
3 doses of iNTS-TCV full dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-TCV full dose Group in Stage 1 (Europe) and to participants in iNTS-TCV full dose Group in Stage 2 (Africa).
BIOLOGICALInvasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) full dose
3 doses of iNTS-GMMA full dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-GMMA + TCV full dose Group in Stage 1 (Europe) and to participants in the iNTS-GMMA + TCV full dose Group in Stage 2 (Africa).
BIOLOGICALInvasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) low dose
3 doses of iNTS-TCV low dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-TCV low dose Group in Stage 1 (Europe).
BIOLOGICALInvasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) low dose
3 doses of iNTS-GMMA low dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-GMMA and TCV low doses Group in Stage 1 (Europe).
BIOLOGICALTyphoid conjugate vaccine (TCV) low dose
3 doses of TCV low dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-GMMA and TCV low doses Group in Stage 1 (Europe).
BIOLOGICALTyphoid conjugate vaccine (TCV) full dose
3 doses of TCV full dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-GMMA + TCV full dose Group in Stage 1 (Europe) and to participants in the iNTS-GMMA + TCV full dose Group in Stage 2 (Africa).
1 dose of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine administered intramuscularly at Day 1 to participants in the Control Group in Stage 2 (Africa).
1 dose of GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine administered intramuscularly at Day 57 to participants in the Control Group in Stage 2 (Africa).
COMBINATION_PRODUCTSanofi Pasteur's Typhoid Vi polysaccharide vaccine
1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine administered intramuscularly at Day 169 to participants in the Control Group in Stage 2 (Africa).
DRUGPlacebo
3 doses of Placebo administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the Placebo Group in Stage 1 (Europe).
OTHERSaline
3 doses of saline solution administered intramuscularly at Day 1, Day 57, and Day 169 to the participants.
Sponsors
Biomedical Advanced Research and Development Authority
Wellcome Trust
Global Antimicrobial Resistance Innovation Fund-(GAMRIF)
Bill and Melinda Gates Foundation
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Data will be collected in an observer-blind manner.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants, who, in the opinion of the Investigator, can and will comply with the requirements of the protocol. * Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study-specific procedure. * Healthy participants as established by medical history, clinical examination, and laboratory assessment. * Participant satisfying screening requirements. * A male or female between and including 18 and 50 years of age at the time of the first study intervention administration. * Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, or post-menopause. * Female participants of childbearing potential may be enrolled in the trial if the participant: * Has practiced adequate contraception for 1 month prior to study intervention administration, and * Has a negative pregnancy test on the day of study intervention administration, and * Has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series. * Blood sample for simultaneous follicle-stimulating hormone (FSH) and estradiol levels may be collected at the discretion of the Investigator to confirm non-reproductive potential according to local laboratory reference range. * Genetic testing for HLA-B27 will be performed at Screening and only participants with a negative result will be allowed to participate in the study\*. * Only for Stage 1. * For Malawi (Stage 2), the participant lives in Blantyre and has agreed to remain in Blantyre for the study duration.
Exclusion criteria
Medical Conditions * Known exposure to S. Typhi and nontyphoidal Salmonella confirmed by blood culture during the period starting 3 years prior to first study intervention administration confirmed using past medical history. * History of any reaction or hypersensitivity associated with any component of the study interventions. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests. * Recurrent history or uncontrolled neurological disorders or seizures. * Any clinically significant\* hematological and/or biochemical laboratory abnormality. * The Investigator should use his/her clinical judgment to decide which abnormalities are clinically significant from the panel of tests in the list of safety assays. * Clinical conditions representing a contraindication to IM injections and/or blood draws. * Any behavioral or cognitive impairment or psychiatric disease that in the opinion of the Investigator, may interfere with the participant's ability to participate in the study. * Confirmed positive COVID-19 polymerase chain reaction or lateral flow test during the period starting 28 days before the first administration of study vaccines (Day -28 to Day 1). * Acute or chronic illness which may be severe enough to preclude participation. * Any other clinical condition that, in the opinion of the Investigator, might pose additional risk to the participant due to participation in the study. * All medical conditions will be assessed by the Investigator who may use his/her discretion to decide if the participant meets the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | At Day 197 (28 days after the third study intervention administration) compared to Baseline (Day 169) | Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 169 (baseline) and Day 197 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 197)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Within 7 days post vaccination (day of administration and 6 subsequent days post-third vaccination on Day 169) | The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature \>=38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade. |
| Stage 2: Number of Participants With Any Unsolicited AE After the First Study Intervention Administration | Within 28 days post vaccination (day of administration and 27 subsequent days post-first vaccination on Day 1) | An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade. |
| Stage 2: Number of Participants With Any Unsolicited AE After the Second Study Intervention Administration | Within 28 days post vaccination (day of administration and 27 subsequent days post-second vaccination on Day 57) | An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade. |
| Stage 2: Number of Participants With Any Unsolicited AE After the Third Study Intervention Administration | Within 28 days post vaccination (day of administration and 27 subsequent days post-third vaccination on Day 169) | An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade. |
| Stage 2: Number of Participants With Any SAEs | From first study intervention administration (Day 1) up to 28 days after the third study intervention administration (Day 197) | An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade. |
| Stage 2: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | From first study intervention administration (Day 1) up to 28 days after the third study intervention (Day 197) | Any AEs including SAEs that lead to withdrawal from the study are considered under this outcome measure. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade. |
| Stage 2: Number of Participants With Any AEs/SAEs Leading to Withholding Further Study Intervention Administration | From first study intervention administration (Day 1) up to 28 days after the third study intervention (Day 197) | AEs/SAEs that lead to withholding of the study intervention administration were considered under this outcome measure. Any = occurrence of the event regardless of intensity grade. |
| Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | At Day 8 (7 days after the first study intervention administration) compared to Baseline (Day 1) | Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 1 (baseline) and Day 8 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 8)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | At Day 64 (7 days after the second study intervention administration) compared to Baseline (Day 57) | Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 57 (baseline) and Day 64 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 64)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | At Day 176 (7 days after the third study intervention administration) compared to Baseline (Day 169) | Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 169 (baseline) and Day 176 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 176)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | At Day 29 (28 days after the first study intervention administration) compared to Baseline (Day 1) | Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 1 (baseline) and Day 29 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 29)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | At Day 85 (28 days after the second study intervention administration) compared to Baseline (Day 57) | Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 57 (baseline) and Day 85 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 85)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Within 7 days post vaccination (day of administration and 6 subsequent days post-first vaccination on Day 1) | The solicited administration site events included redness (erythema), pain, and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade. |
| Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Within 7 days post vaccination (day of administration and 6 subsequent days post-second vaccination on Day 57) | The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade. |
| Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Within 7 days post vaccination (day of administration and 6 subsequent days post-third vaccination on Day 169) | The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade. |
| Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Within 7 days post vaccination (day of administration and 6 subsequent days post-first vaccination on Day 1) | The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature equal to or above (\>=) 38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade. |
| Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Within 7 days post vaccination (day of administration and 6 subsequent days post-second vaccination on Day 57) | The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature equal to or above (≥) 38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade. |
| Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Within 7 days post vaccination (day of administration and 6 subsequent days post-third vaccination on Day 169) | The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature equal to or above (≥) 38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade. |
| Stage 1: Number of Participants With Any Unsolicited Adverse Events (AE) After the First Study Intervention Administration | Within 28 days post vaccination (day of administration and 27 subsequent days post-first vaccination on Day 1) | An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade. |
| Stage 1: Number of Participants With Any Unsolicited AEs After the Second Study Intervention Administration | Within 28 days post vaccination (day of administration and 27 subsequent days post-second vaccination on Day 57) | An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade. |
| Stage 1: Number of Participants With Any Unsolicited AEs After the Third Study Intervention Administration | Within 28 days post vaccination (day of administration and 27 subsequent days post-third vaccination on Day 169) | An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade. |
| Stage 1: Number of Participants With Any Serious Adverse Events (SAEs) | From first study intervention administration (Day 1) up to 28 days after the third study intervention administration (Day 197) | An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade. |
| Stage 1: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | From first study intervention administration (Day 1) up to 28 days after the third study intervention administration (Day 197) | An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. An AE is any untoward medical occurrence (an unfavourable/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. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade. |
| Stage 1: Number of Participants With Any AEs/SAEs Leading to Withholding Further Study Intervention Administration | From first study intervention administration (Day 1) up to 28 days after the third study intervention administration (Day 197) | An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. An AE is any untoward medical occurrence (an unfavourable/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. AEs/SAEs that lead to withholding of the study intervention administration were considered under this outcome measure. Any = occurrence of the event regardless of intensity grade. |
| Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | At Day 8 (7 days after the first study intervention administration) compared to Baseline (Day 1) | Assessed hepatic laboratory parameters included alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\], and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 1 (baseline) and Day 8 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 8)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | At Day 64 (7 days after the second study intervention administration) compared to Baseline (Day 57) | Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 57 (baseline) and Day 64 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 64)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | At Day 176 (7 days after the third study intervention administration) compared to Baseline (Day 169) | Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 169 (baseline) and Day 176 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 176)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | At Day 29 (28 days after the first study intervention administration) compared to Baseline (Day 1) | Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 1 (baseline) and Day 29 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 29)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | At Day 85 (28 days after the second study intervention administration) compared to Baseline (Day 57) | Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 57 (baseline) and Day 85 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 85)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | At Day 197 (28 days after the third study intervention administration) compared to Baseline (Day 169) | Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 169 (baseline) and Day 197 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 197)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Within 7 days post vaccination (day of administration and 6 subsequent days post-first vaccination on Day 1) | The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade. |
| Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Within 7 days post vaccination (day of administration and 6 subsequent days post-second vaccination on Day 57) | The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade. |
| Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Within 7 days post vaccination (day of administration and 6 subsequent days post-third vaccination on Day 169) | The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade. |
| Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Within 7 days post vaccination (day of administration and 6 subsequent days post-first vaccination on Day 1) | The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature \>=38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade. |
| Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration | Within 7 days post vaccination (day of administration and 6 subsequent days post-second vaccination on Day 57) | The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature \>=38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stage 1 and Stage 2: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | From 28 days after the third study intervention administration (Day 197) up to study end (Day 337) | Any AEs including SAEs that lead to withdrawal from the study are considered under this outcome measure. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade. |
| Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | At Days 1, 57, and 169 (before each study intervention administration) and at Days 29, 85, and 197 (28 days after each study intervention administration) | Anti-Vi antigen (Ag) total IgG GMCs were assessed. Blood samples were collected at specified timepoint for each component as measured by Enzyme-Linked Immunosorbent Assay (ELISA). The lower limit of quantification (LLOQ) for antibody concentrations was \>=2.2 microgram per milliliter (µg/mL). In case the measured antibody concentration fell below 2.2 µg/mL, a value of half the LLOQ value was imputed. |
| Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | At Days 1, 57, and 169 (before each study intervention administration) and at Days 29, 85, and 197 (28 days after each study intervention administration) | Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG GMCs were assessed. Blood samples were collected at specified timepoint for each component as measured by Enzyme-Linked Immunosorbent Assay (ELISA). |
| Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | At 28 days after each study intervention administration compared to each study intervention administration baseline (Day 29 versus Day 1, Day 85 versus Day 57 and Day 197 versus Day 169) | Anti-Vi antigen (Ag) total IgG, Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG within-participant GMRs were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint. |
| Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | At Days 29, 85, and 197 (28 days after each study intervention administration) compared to Day 1 (first study intervention administration) | Anti-Vi Ag total IgG, Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG antibody concentrations were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA. |
| Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | At Days 1, 57 and 169 (before each study intervention administration) and at Days 29, 85 and 197 (28 days after each study intervention administration) | Blood samples were collected at specified timepoint for each component as measured by ELISA. |
| Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | At Days 1, 57, and 169 (before each study intervention administration) and at Days 29, 85, and 197 (28 days after each study intervention administration) | Anti-Vi Ag total IgG GMCs and between group ratios were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA. |
| Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | At Days 1, 57, and 169 (before each study intervention administration) and at Days 29, 85, and 197 (28 days after each study intervention administration) | Anti-S. Typhimurium OAg total IgG and Anti-S. Enteritidis OAg total IgG GMCs and between group ratios were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA. |
| Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | At 28 days after each study intervention administration compared to each study intervention administration baseline (Day 29 versus Day 1, Day 85 versus Day 57 and Day 197 versus Day 169) | Anti-Vi antigen (Ag) total IgG, Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG within-participant GMRs were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint. |
| Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | At Days 29, 85, and 197 (28 days after each study intervention administration) compared to Day 1 (first study intervention administration baseline) | Anti-Vi Ag total IgG, Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG antibody concentrations were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA. |
| Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | At Days 1, 57 and 169 (before each study intervention administration) and at Days 29, 85 and 197 (28 days after each study intervention administration) | Blood samples were collected at specified timepoint for each component as measured by ELISA. |
| Stage 1 and Stage 2: Number of Participants With Any SAEs | From 28 days after the third study intervention administration (Day 197) up to study end (Day 337) | An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade. |
Countries
Belgium, Malawi
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169. | 4 |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group European participants were randomized to receive 3 doses of iNTS-GMMA low dose vaccine and 3 doses of TCV low dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169. | 4 |
| Stage 1: iNTS-TCV Full Dose Group European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169. | 16 |
| Stage 1: iNTS-GMMA + TCV Full Dose Group European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169. | 16 |
| Stage 1: Placebo Group European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169. | 10 |
| Stage 2: iNTS-TCV Full Dose Group African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169. | 45 |
| Stage 2: iNTS-GMMA + TCV Full Dose Group African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169. | 45 |
| Stage 2: Control Group African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169. | 15 |
| Total | 155 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Other | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 2 | 1 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: iNTS-TCV Full Dose Group | Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Placebo Group | Stage 2: iNTS-TCV Full Dose Group | Stage 2: iNTS-GMMA + TCV Full Dose Group | Stage 2: Control Group | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 21.8 Years STANDARD_DEVIATION 2.5 | 35.8 Years STANDARD_DEVIATION 12 | 36.8 Years STANDARD_DEVIATION 11.1 | 33.1 Years STANDARD_DEVIATION 11.3 | 34.7 Years STANDARD_DEVIATION 9.5 | 28.2 Years STANDARD_DEVIATION 6.3 | 28.5 Years STANDARD_DEVIATION 6.3 | 29.7 Years STANDARD_DEVIATION 9.1 | 30.3 Years STANDARD_DEVIATION 8.6 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 45 Participants | 45 Participants | 14 Participants | 104 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 4 Participants | 4 Participants | 15 Participants | 16 Participants | 9 Participants | 0 Participants | 0 Participants | 0 Participants | 48 Participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 11 Participants | 10 Participants | 10 Participants | 26 Participants | 23 Participants | 5 Participants | 90 Participants |
| Sex: Female, Male Male | 0 Participants | 3 Participants | 5 Participants | 6 Participants | 0 Participants | 19 Participants | 22 Participants | 10 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 | 0 / 16 | 0 / 16 | 0 / 10 | 0 / 45 | 0 / 45 | 0 / 15 |
| other Total, other adverse events | 4 / 4 | 4 / 4 | 16 / 16 | 16 / 16 | 9 / 10 | 43 / 45 | 45 / 45 | 15 / 15 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 0 / 16 | 1 / 16 | 0 / 10 | 0 / 45 | 2 / 45 | 1 / 15 |
Outcome results
Primary
Stage 1: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. An AE is any untoward medical occurrence (an unfavourable/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. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.
Time frame: From first study intervention administration (Day 1) up to 28 days after the third study intervention administration (Day 197)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | 0 Participants |
Primary
Stage 1: Number of Participants With Any AEs/SAEs Leading to Withholding Further Study Intervention Administration
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. An AE is any untoward medical occurrence (an unfavourable/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. AEs/SAEs that lead to withholding of the study intervention administration were considered under this outcome measure. Any = occurrence of the event regardless of intensity grade.
Time frame: From first study intervention administration (Day 1) up to 28 days after the third study intervention administration (Day 197)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any AEs/SAEs Leading to Withholding Further Study Intervention Administration | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any AEs/SAEs Leading to Withholding Further Study Intervention Administration | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any AEs/SAEs Leading to Withholding Further Study Intervention Administration | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any AEs/SAEs Leading to Withholding Further Study Intervention Administration | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any AEs/SAEs Leading to Withholding Further Study Intervention Administration | 0 Participants |
Primary
Stage 1: Number of Participants With Any 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, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade.
Time frame: From first study intervention administration (Day 1) up to 28 days after the third study intervention administration (Day 197)
Population: The analysis was performed on the exposed set, which included all participants who received at least 1 dose of the study intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Serious Adverse Events (SAEs) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Serious Adverse Events (SAEs) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Serious Adverse Events (SAEs) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Serious Adverse Events (SAEs) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Serious Adverse Events (SAEs) | 0 Participants |
Primary
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
The solicited administration site events included redness (erythema), pain, and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.
Time frame: Within 7 days post vaccination (day of administration and 6 subsequent days post-first vaccination on Day 1)
Population: The analysis was performed on the Solicited safety set, which included all participants who received first dose of the study intervention and who had solicited safety data in the 7 days following first intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-TCV low dose | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, saline | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, TCV low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, Saline | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, Placebo | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, TCV low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, TCV low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-TCV Low | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, Placebo | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-TCV low dose | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, Placebo | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, TCV low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-TCV low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-TCV low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, saline | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, TCV low dose | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-GMMA low dose | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-TCV Low | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, Saline | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, TCV low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, Placebo | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, Placebo | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-GMMA low dose | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, Placebo | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, Placebo | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-TCV low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, Saline | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, TCV low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-TCV full dose | 4 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, Placebo | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-TCV low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, saline | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, TCV low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-TCV full dose | 16 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, Placebo | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-TCV Low | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, TCV low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-TCV full dose | 4 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, Placebo | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-GMMA full dose | 16 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, TCV full dose | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-GMMA full dose | 5 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, Placebo | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, Placebo | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-TCV Low | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, TCV low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-GMMA full dose | 3 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, Saline | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, TCV low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, saline | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-TCV low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, TCV low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-TCV low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, TCV low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, Placebo | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, saline | 3 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-TCV full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-TCV low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, TCV full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, Placebo | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, Saline | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, Placebo | 3 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-TCV full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-TCV full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-TCV Low | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, TCV low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, TCV low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-TCV low dose | 0 Participants |
Primary
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.
Time frame: Within 7 days post vaccination (day of administration and 6 subsequent days post-second vaccination on Day 57)
Population: The analysis was performed on the Solicited safety set, which included all participants who received second dose of the study intervention and who had solicited safety data in the 7 days following second intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, Saline | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, TCV low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-TCV Low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, Placebo | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, Placebo | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, Placebo | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-TCV low dose | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, TCV low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, TCV low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, saline | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-TCV low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, Saline | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-GMMA low dose | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, TCV low dose | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, Placebo | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-TCV Low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-TCV low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, TCV low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, TCV low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, Placebo | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, Placebo | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-TCV low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, saline | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-TCV full dose | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-TCV full dose | 6 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, Placebo | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, Saline | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, Placebo | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-TCV low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-TCV low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, saline | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, TCV low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-TCV full dose | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, TCV low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, Placebo | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-TCV Low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, TCV low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, saline | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, TCV low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, TCV full dose | 7 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-TCV low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, Saline | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, Placebo | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, Placebo | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-GMMA full dose | 3 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, TCV low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-TCV Low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, Placebo | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-GMMA full dose | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, TCV low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-GMMA full dose | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-TCV low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, Placebo | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-TCV low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, Saline | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, TCV low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-TCV full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, Placebo | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-TCV low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, saline | 2 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, TCV low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-TCV full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, TCV full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, Placebo | 5 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-TCV Low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, TCV low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-TCV full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-GMMA full dose | 0 Participants |
Primary
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.
Time frame: Within 7 days post vaccination (day of administration and 6 subsequent days post-third vaccination on Day 169)
Population: The analysis was performed on the Solicited safety set, which included all participants who received third dose of the study intervention and who had solicited safety data in the 7 days following third intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, TCV low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, saline | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, TCV low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, Placebo | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, Placebo | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, Placebo | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-TCV low dose | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-TCV low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, TCV low dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-TCV Low | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, Saline | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, saline | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, TCV low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, Placebo | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-GMMA low dose | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-TCV Low | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, TCV low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, TCV low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-TCV low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, Placebo | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-TCV low dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, Placebo | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, Saline | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-TCV low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-TCV Low | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, Saline | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-TCV full dose | 11 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, Placebo | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-TCV full dose | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, Placebo | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, TCV low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, Placebo | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, TCV low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, saline | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-TCV full dose | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-TCV low dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, TCV low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-GMMA full dose | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, TCV full dose | 2 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, Placebo | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-TCV Low | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, TCV low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-GMMA low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-GMMA full dose | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, Placebo | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-TCV low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, Saline | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, TCV low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, TCV low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-GMMA full dose | 4 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, TCV full dose | 4 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, Placebo | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-TCV low dose | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, saline | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, Saline | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-TCV low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, Placebo | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, Placebo | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-TCV full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-TCV low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, TCV low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-TCV full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, saline | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-TCV Low | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, Placebo | 5 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, TCV full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-TCV full dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, TCV low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-GMMA low dose | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, TCV low dose | 0 Participants |
Primary
Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration
The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature equal to or above (\>=) 38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade.
Time frame: Within 7 days post vaccination (day of administration and 6 subsequent days post-first vaccination on Day 1)
Population: The analysis was performed on the Solicited safety set, which included all participants who received first dose of the study intervention and who had solicited safety data in the 7 days following first intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Fever | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Fatigue | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Myalgia | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Headache | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Arthralgia | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Fatigue | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Myalgia | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Arthralgia | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Fever | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Headache | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Headache | 6 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Myalgia | 6 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Fever | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Fatigue | 7 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Arthralgia | 3 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Myalgia | 6 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Arthralgia | 3 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Fatigue | 11 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Headache | 5 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Fever | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Headache | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Fatigue | 2 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Arthralgia | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Fever | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Myalgia | 0 Participants |
Primary
Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration
The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature equal to or above (≥) 38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade.
Time frame: Within 7 days post vaccination (day of administration and 6 subsequent days post-second vaccination on Day 57)
Population: The analysis was performed on the Solicited safety set, which included all participants who received second dose of the study intervention and who had solicited safety data in the 7 days following second intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Fatigue | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Fever | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Headache | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Myalgia | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Arthralgia | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Myalgia | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Fatigue | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Fever | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Arthralgia | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Headache | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Fatigue | 7 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Arthralgia | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Headache | 5 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Fever | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Myalgia | 4 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Fatigue | 6 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Headache | 6 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Myalgia | 4 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Fever | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Arthralgia | 2 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Arthralgia | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Fever | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Myalgia | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Headache | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration | Fatigue | 1 Participants |
Primary
Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration
The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature equal to or above (≥) 38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade.
Time frame: Within 7 days post vaccination (day of administration and 6 subsequent days post-third vaccination on Day 169)
Population: The analysis was performed on the Solicited safety set, which included all participants who received third dose of the study intervention and who had solicited safety data in the 7 days following third intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Myalgia | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Arthralgia | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Fever | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Fatigue | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Headache | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Myalgia | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Headache | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Fatigue | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Fever | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Arthralgia | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Headache | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Arthralgia | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Fatigue | 4 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Myalgia | 5 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Fever | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Fever | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Arthralgia | 2 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Myalgia | 10 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Headache | 7 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Fatigue | 7 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Headache | 3 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Myalgia | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Arthralgia | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Fever | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Fatigue | 0 Participants |
Primary
Stage 1: Number of Participants With Any Unsolicited Adverse Events (AE) After the First Study Intervention Administration
An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade.
Time frame: Within 28 days post vaccination (day of administration and 27 subsequent days post-first vaccination on Day 1)
Population: The analysis was performed on the unsolicited safety set, which included all participants who received the first dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Unsolicited Adverse Events (AE) After the First Study Intervention Administration | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Unsolicited Adverse Events (AE) After the First Study Intervention Administration | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Unsolicited Adverse Events (AE) After the First Study Intervention Administration | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Unsolicited Adverse Events (AE) After the First Study Intervention Administration | 13 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Unsolicited Adverse Events (AE) After the First Study Intervention Administration | 4 Participants |
Primary
Stage 1: Number of Participants With Any Unsolicited AEs After the Second Study Intervention Administration
An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade.
Time frame: Within 28 days post vaccination (day of administration and 27 subsequent days post-second vaccination on Day 57)
Population: The analysis was performed on the unsolicited safety set, which included all participants who received the second dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Unsolicited AEs After the Second Study Intervention Administration | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Unsolicited AEs After the Second Study Intervention Administration | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Unsolicited AEs After the Second Study Intervention Administration | 8 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Unsolicited AEs After the Second Study Intervention Administration | 8 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Unsolicited AEs After the Second Study Intervention Administration | 2 Participants |
Primary
Stage 1: Number of Participants With Any Unsolicited AEs After the Third Study Intervention Administration
An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade.
Time frame: Within 28 days post vaccination (day of administration and 27 subsequent days post-third vaccination on Day 169)
Population: The analysis was performed on the unsolicited safety set, which included all participants who received the third dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Any Unsolicited AEs After the Third Study Intervention Administration | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Any Unsolicited AEs After the Third Study Intervention Administration | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Any Unsolicited AEs After the Third Study Intervention Administration | 3 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Any Unsolicited AEs After the Third Study Intervention Administration | 5 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Any Unsolicited AEs After the Third Study Intervention Administration | 5 Participants |
Primary
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 169 (baseline) and Day 176 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 176)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 176 (7 days after the third study intervention administration) compared to Baseline (Day 169)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - below (Day 176) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - within (Day 176) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - within (Day 176) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - above (Day 176) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - within (Day 176) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - within (Day 176) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - above (Day 176) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - above (Day 176) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - within (Day 176) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - within (Day 176) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - within (Day 176) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - within (Day 176) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - within (Day 176) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - within (Day 176) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - within (Day 176) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - within (Day 176) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - within (Day 176) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - within (Day 176) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - within (Day 176) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - within (Day 176) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - within (Day 176) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - within (Day 176) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - within (Day 176) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - within (Day 176) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - within (Day 176) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - within (Day 176) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - within (Day 176) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - within (Day 176) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - within (Day 176) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - within (Day 176) | 9 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - above (Day 176) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - within (Day 176) | 11 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - within (Day 176) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - within (Day 176) | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - within (Day 176) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - within (Day 176) | 10 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - within (Day 176) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - within (Day 176) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - within (Day 176) | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - within (Day 176) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - within (Day 176) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - within (Day 176) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - within (Day 176) | 8 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - within (Day 176) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - above (Day 176) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - within (Day 176) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - above (Day 176) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - within (Day 176) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - within (Day 176) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - within (Day 176) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - within (Day 176) | 13 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - above (Day 176) | 3 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - within (Day 176) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - within (Day 176) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - within (Day 176) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - within (Day 176) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - within (Day 176) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - within (Day 176) | 12 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - within (Day 176) | 13 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - within (Day 176) | 10 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - within (Day 176) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - within (Day 176) | 13 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - within (Day 176) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - within (Day 176) | 12 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - within (Day 176) | 11 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - within (Day 176) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - within (Day 176) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - within (Day 176) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - within (Day 176) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - within (Day 176) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - above (Day 176) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - within (Day 176) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - within (Day 176) | 6 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - above (Day 176) | 2 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - within (Day 176) | 8 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - within (Day 176) | 9 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - within (Day 176) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - above (Day 176) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - within (Day 176) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - within (Day 176) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - within (Day 176) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - within (Day 176) | 9 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - above (Day 176) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - above (Day 176) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - above (Day 176) | 0 Participants |
Primary
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 169 (baseline) and Day 197 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 197)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 197 (28 days after the third study intervention administration) compared to Baseline (Day 169)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - within (Day 197) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - within (Day 197) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - within (Day 197) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - within (Day 197) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - within (Day 197) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - within (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - within (Day 197) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - within (Day 197) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Within (baseline) - within (Day 197) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - above (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - within (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - within (Day 197) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - within (Day 197) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - within (Day 197) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - within (Day 197) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - within (Day 197) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - within (Day 197) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - within (Day 197) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - within (Day 197) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Within (baseline) - within (Day 197) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Within (baseline) - below (Day 197) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - within (Day 197) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - within (Day 197) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - within (Day 197) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - within (Day 197) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - within (Day 197) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - within (Day 197) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - within (Day 197) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - within (Day 197) | 11 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - within (Day 197) | 10 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - within (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - above (Day 197) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - within (Day 197) | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - within (Day 197) | 11 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - within (Day 197) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - within (Day 197) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - within (Day 197) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - below (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - within (Day 197) | 11 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - within (Day 197) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - within (Day 197) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - below (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - within (Day 197) | 9 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - within (Day 197) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - within (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Within (baseline) - below (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Within (baseline) - within (Day 197) | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - within (Day 197) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - within (Day 197) | 13 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - within (Day 197) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - within (Day 197) | 13 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - below (Day 197) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Above (baseline) - within (Day 197) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - within (Day 197) | 13 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - within (Day 197) | 13 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - within (Day 197) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - below (Day 197) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - within (Day 197) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - within (Day 197) | 12 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - within (Day 197) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - within (Day 197) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - within (Day 197) | 13 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Within (baseline) - within (Day 197) | 12 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - within (Day 197) | 11 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - within (Day 197) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - within (Day 197) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - within (Day 197) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - within (Day 197) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - above (Day 197) | 2 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - within (Day 197) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - within (Day 197) | 7 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - within (Day 197) | 9 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Within (baseline) - within (Day 197) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - above (Day 197) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - within (Day 197) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - within (Day 197) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells (WBC) | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - within (Day 197) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - within (Day 197) | 9 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - above (Day 197) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - above (Day 197) | 0 Participants |
Primary
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 1 (baseline) and Day 29 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 29)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 29 (28 days after the first study intervention administration) compared to Baseline (Day 1)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - within (Day 29) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - above (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - within (Day 29) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - within (Day 29) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - within (Day 29) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - above (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - within (Day 29) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - within (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - within (Day 29) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - within (Day 29) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - above (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - within (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - within (Day 29) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - within (Day 29) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - within (Day 29) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - within (Day 29) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - within (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - within (Day 29) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - within (Day 29) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - within (Day 29) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - within (Day 29) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - within (Day 29) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - within (Day 29) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - within (Day 29) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - within (Day 29) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - within (Day 29) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - within (Day 29) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - within (Day 29) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - below (Day 29) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - within (Day 29) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - within (Day 29) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - within (Day 29) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - within (Day 29) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - within (Day 29) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - above (Day 29) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - within (Day 29) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - within (Day 29) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - within (Day 29) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - within (Day 29) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - within (Day 29) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - above (Day 29) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - within (Day 29) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - within (Day 29) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - within (Day 29) | 16 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - within (Day 29) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - within (Day 29) | 16 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - within (Day 29) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - above (Day 29) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - within (Day 29) | 16 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - within (Day 29) | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - within (Day 29) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - above (Day 29) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - above (Day 29) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - within (Day 29) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - within (Day 29) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - within (Day 29) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - within (Day 29) | 16 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - within (Day 29) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - within (Day 29) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - within (Day 29) | 16 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - within (Day 29) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - within (Day 29) | 16 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - within (Day 29) | 16 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - within (Day 29) | 16 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - within (Day 29) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - within (Day 29) | 16 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - within (Day 29) | 2 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - within (Day 29) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - within (Day 29) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - within (Day 29) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - within (Day 29) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - within (Day 29) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - within (Day 29) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - within (Day 29) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - above (Day 29) | 2 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - within (Day 29) | 8 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - within (Day 29) | 9 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - within (Day 29) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - within (Day 29) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - within (Day 29) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - within (Day 29) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - within (Day 29) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - within (Day 29) | 9 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - above (Day 29) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - within (Day 29) | 9 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - above (Day 29) | 0 Participants |
Primary
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 57 (baseline) and Day 64 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 64)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 64 (7 days after the second study intervention administration) compared to Baseline (Day 57)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - within (Day 64) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - within (Day 64) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - above (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - within (Day 64) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - within (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - within (Day 64) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - above (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - within (Day 64) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - above (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - within (Day 64) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - within (Day 64) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - above (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - within (Day 64) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - within (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - within (Day 64) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - within (Day 64) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - within (Day 64) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - within (Day 64) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - below (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - below (Day 64) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - within (Day 64) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - within (Day 64) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - within (Day 64) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - within (Day 64) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - within (Day 64) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - within (Day 64) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - within (Day 64) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - within (Day 64) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - within (Day 64) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - within (Day 64) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - within (Day 64) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - within (Day 64) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - within (Day 64) | 4 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - within (Day 64) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - within (Day 64) | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - within (Day 64) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - above (Day 64) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - within (Day 64) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - within (Day 64) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - above (Day 64) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - within (Day 64) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - above (Day 64) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - within (Day 64) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - within (Day 64) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - within (Day 64) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - within (Day 64) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - within (Day 64) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - within (Day 64) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - within (Day 64) | 11 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - within (Day 64) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - above (Day 64) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - above (Day 64) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - above (Day 64) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - above (Day 64) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - below (Day 64) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - within (Day 64) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - within (Day 64) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - within (Day 64) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - within (Day 64) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - within (Day 64) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - within (Day 64) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - within (Day 64) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - within (Day 64) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - within (Day 64) | 13 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - within (Day 64) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - above (Day 64) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - above (Day 64) | 2 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - above (Day 64) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - within (Day 64) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - above (Day 64) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - within (Day 64) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - within (Day 64) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - within (Day 64) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - within (Day 64) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - within (Day 64) | 13 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - within (Day 64) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - within (Day 64) | 9 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - above (Day 64) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - within (Day 64) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - within (Day 64) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - above (Day 64) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - within (Day 64) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - within (Day 64) | 2 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - within (Day 64) | 7 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - within (Day 64) | 6 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - within (Day 64) | 7 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - within (Day 64) | 2 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - above (Day 64) | 2 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - within (Day 64) | 2 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - within (Day 64) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - within (Day 64) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - above (Day 64) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - within (Day 64) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - within (Day 64) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - within (Day 64) | 9 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - above (Day 64) | 0 Participants |
Primary
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Assessed hepatic laboratory parameters included alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\], and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 1 (baseline) and Day 8 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 8)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 8 (7 days after the first study intervention administration) compared to Baseline (Day 1)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - within (Day 8) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - within (Day 8) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - within (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - within (Day 8) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - within (Day 8) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - above (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - within (Day 8) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - within (Day 8) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - within (Day 8) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - within (Day 8) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - above (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - within (Day 8) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - within (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - within (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - within (Day 8) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - within (Day 8) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - within (Day 8) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - within (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - within (Day 8) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - within (Day 8) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - within (Day 8) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - within (Day 8) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - within (Day 8) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - within (Day 8) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - above (Day 8) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - below (Day 8) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - within (Day 8) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - within (Day 8) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - within (Day 8) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - within (Day 8) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - within (Day 8) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - within (Day 8) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - within (Day 8) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - within (Day 8) | 16 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - within (Day 8) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - within (Day 8) | 16 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - within (Day 8) | 11 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - within (Day 8) | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - above (Day 8) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - within (Day 8) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - within (Day 8) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - within (Day 8) | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - within (Day 8) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - within (Day 8) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - above (Day 8) | 5 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - above (Day 8) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - within (Day 8) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - within (Day 8) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - within (Day 8) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - above (Day 8) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - within (Day 8) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - above (Day 8) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - above (Day 8) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - within (Day 8) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - above (Day 8) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - above (Day 8) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - within (Day 8) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - above (Day 8) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - within (Day 8) | 16 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - within (Day 8) | 16 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - within (Day 8) | 13 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - within (Day 8) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - above (Day 8) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - above (Day 8) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - within (Day 8) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - within (Day 8) | 16 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - within (Day 8) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - within (Day 8) | 16 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - within (Day 8) | 16 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - within (Day 8) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - above (Day 8) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - within (Day 8) | 16 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - within (Day 8) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - within (Day 8) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - within (Day 8) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - above (Day 8) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - within (Day 8) | 16 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - within (Day 8) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - within (Day 8) | 9 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - above (Day 8) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - within (Day 8) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - above (Day 8) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - within (Day 8) | 9 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - within (Day 8) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - within (Day 8) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - within (Day 8) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - above (Day 8) | 2 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - within (Day 8) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - within (Day 8) | 8 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - below (Day 8) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - within (Day 8) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - within (Day 8) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - within (Day 8) | 9 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - within (Day 8) | 9 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - below (Day 8) | 0 Participants |
Primary
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 57 (baseline) and Day 85 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 85)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 85 (28 days after the second study intervention administration) compared to Baseline (Day 57)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - within (Day 85) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - above (Day 85) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - within (Day 85) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - within (Day 85) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - within (Day 85) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - within (Day 85) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - within (Day 85) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - within (Day 85) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - within (Day 85) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - within (Day 85) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - above (Day 85) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - within (Day 85) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - within (Day 85) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - within (Day 85) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - within (Day 85) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - within (Day 85) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - within (Day 85) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - below (Day 85) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - within (Day 85) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - within (Day 85) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - within (Day 85) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - within (Day 85) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - below (Day 85) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - within (Day 85) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - within (Day 85) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - within (Day 85) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - within (Day 85) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - below (Day 85) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - within (Day 85) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - within (Day 85) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - within (Day 85) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - within (Day 85) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - within (Day 85) | 11 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - within (Day 85) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - above (Day 85) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - above (Day 85) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - within (Day 85) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - within (Day 85) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - within (Day 85) | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - above (Day 85) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - above (Day 85) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - within (Day 85) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - within (Day 85) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - within (Day 85) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - within (Day 85) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - within (Day 85) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - within (Day 85) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - within (Day 85) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - above (Day 85) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - within (Day 85) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - above (Day 85) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - within (Day 85) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - within (Day 85) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - within (Day 85) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - within (Day 85) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - above (Day 85) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - within (Day 85) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - above (Day 85) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - above (Day 85) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - within (Day 85) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - within (Day 85) | 13 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - within (Day 85) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - above (Day 85) | 2 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - below (Day 85) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - above (Day 85) | 2 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - within (Day 85) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - within (Day 85) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - above (Day 85) | 1 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - within (Day 85) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - within (Day 85) | 11 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - within (Day 85) | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - within (Day 85) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - within (Day 85) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - within (Day 85) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - within (Day 85) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - within (Day 85) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - above (Day 85) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - above (Day 85) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - within (Day 85) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - within (Day 85) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - within (Day 85) | 7 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - within (Day 85) | 6 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - within (Day 85) | 4 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - within (Day 85) | 7 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - within (Day 85) | 3 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - within (Day 85) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - within (Day 85) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - within (Day 85) | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - within (Day 85) | 10 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - within (Day 85) | 9 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - above (Day 85) | 0 Participants |
Primary
Stage 2: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study
Any AEs including SAEs that lead to withdrawal from the study are considered under this outcome measure. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.
Time frame: From first study intervention administration (Day 1) up to 28 days after the third study intervention (Day 197)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | 0 Participants |
Primary
Stage 2: Number of Participants With Any AEs/SAEs Leading to Withholding Further Study Intervention Administration
AEs/SAEs that lead to withholding of the study intervention administration were considered under this outcome measure. Any = occurrence of the event regardless of intensity grade.
Time frame: From first study intervention administration (Day 1) up to 28 days after the third study intervention (Day 197)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any AEs/SAEs Leading to Withholding Further Study Intervention Administration | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any AEs/SAEs Leading to Withholding Further Study Intervention Administration | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any AEs/SAEs Leading to Withholding Further Study Intervention Administration | 0 Participants |
Primary
Stage 2: Number of Participants With Any 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, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade.
Time frame: From first study intervention administration (Day 1) up to 28 days after the third study intervention administration (Day 197)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any SAEs | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any SAEs | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any SAEs | 0 Participants |
Primary
Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.
Time frame: Within 7 days post vaccination (day of administration and 6 subsequent days post-first vaccination on Day 1)
Population: The analysis was performed on the Solicited safety set, which included all participants who received first dose of the study intervention and who had solicited safety data in the 7 days following first intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-TCV full dose | 38 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-TCV full dose | 7 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, saline | 16 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, saline | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, control | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, control | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-TCV full dose | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, control | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, saline | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, saline | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, TCV full dose | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-GMMA full dose | 7 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, control | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, saline | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, TCV full dose | 20 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-GMMA full dose | 41 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, control | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, TCV full dose | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-GMMA full dose | 10 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, control | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, control | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Redness, saline | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, saline | 5 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Swelling, control | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration | Pain, control | 6 Participants |
Primary
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.
Time frame: Within 7 days post vaccination (day of administration and 6 subsequent days post-second vaccination on Day 57)
Population: The analysis was performed on the Solicited safety set, which included all participants who received second dose of the study intervention and who had solicited safety data in the 7 days following second intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-TCV full dose | 35 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-TCV full dose | 6 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, saline | 14 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, saline | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, control | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, control | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-TCV full dose | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, control | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, saline | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, saline | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, TCV full dose | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-GMMA full dose | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, control | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, saline | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, TCV full dose | 24 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-GMMA full dose | 41 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, control | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, TCV full dose | 6 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-GMMA full dose | 11 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, control | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, control | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Redness, saline | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, saline | 5 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Swelling, control | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration | Pain, control | 9 Participants |
Primary
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.
Time frame: Within 7 days post vaccination (day of administration and 6 subsequent days post-third vaccination on Day 169)
Population: The analysis was performed on the Solicited safety set, which included all participants who received third dose of the study intervention and who had solicited safety data in the 7 days following third intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, saline | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-TCV full dose | 32 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-TCV full dose | 5 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, saline | 10 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, control | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-GMMA full dose | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, saline | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, control | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, control | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-TCV full dose | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, saline | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, saline | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, TCV full dose | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-GMMA full dose | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, control | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, saline | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, TCV full dose | 19 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-GMMA full dose | 35 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, control | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, TCV full dose | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-GMMA full dose | 9 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, control | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, control | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, saline | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, iNTS-TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, TCV full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, saline | 6 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Redness, saline | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, iNTS-GMMA full dose | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Swelling, control | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration | Pain, control | 8 Participants |
Primary
Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration
The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature \>=38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade.
Time frame: Within 7 days post vaccination (day of administration and 6 subsequent days post-first vaccination on Day 1)
Population: The analysis was performed on the Solicited safety set, which included all participants who received first dose of the study intervention and who had solicited safety data in the 7 days following first intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Myalgia | 23 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Headache | 26 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Arthralgia | 12 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Fatigue | 23 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Fever | 8 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Headache | 24 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Arthralgia | 10 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Fatigue | 20 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Myalgia | 21 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Fever | 6 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Fever | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Myalgia | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Arthralgia | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Headache | 5 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration | Fatigue | 4 Participants |
Primary
Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration
The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature \>=38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade.
Time frame: Within 7 days post vaccination (day of administration and 6 subsequent days post-third vaccination on Day 169)
Population: The analysis was performed on the Solicited safety set, which included all participants who received third dose of the study intervention and who had solicited safety data in the 7 days following third intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Myalgia | 17 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Headache | 21 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Arthralgia | 13 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Fatigue | 18 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Fever | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Headache | 23 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Arthralgia | 15 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Fatigue | 18 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Myalgia | 18 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Fever | 9 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Fever | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Myalgia | 4 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Arthralgia | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Headache | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration | Fatigue | 2 Participants |
Primary
Stage 2: Number of Participants With Any Unsolicited AE After the First Study Intervention Administration
An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade.
Time frame: Within 28 days post vaccination (day of administration and 27 subsequent days post-first vaccination on Day 1)
Population: The analysis was performed on the unsolicited safety set, which included all participants who received the first dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Unsolicited AE After the First Study Intervention Administration | 21 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Unsolicited AE After the First Study Intervention Administration | 24 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Unsolicited AE After the First Study Intervention Administration | 8 Participants |
Primary
Stage 2: Number of Participants With Any Unsolicited AE After the Second Study Intervention Administration
An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade.
Time frame: Within 28 days post vaccination (day of administration and 27 subsequent days post-second vaccination on Day 57)
Population: The analysis was performed on the unsolicited safety set, which included all participants who received the second dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Unsolicited AE After the Second Study Intervention Administration | 13 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Unsolicited AE After the Second Study Intervention Administration | 17 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Unsolicited AE After the Second Study Intervention Administration | 3 Participants |
Primary
Stage 2: Number of Participants With Any Unsolicited AE After the Third Study Intervention Administration
An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade.
Time frame: Within 28 days post vaccination (day of administration and 27 subsequent days post-third vaccination on Day 169)
Population: The analysis was performed on the unsolicited safety set, which included all participants who received the third dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Any Unsolicited AE After the Third Study Intervention Administration | 13 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Any Unsolicited AE After the Third Study Intervention Administration | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Any Unsolicited AE After the Third Study Intervention Administration | 1 Participants |
Primary
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 169 (baseline) and Day 176 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 176)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 176 (7 days after the third study intervention administration) compared to Baseline (Day 169)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - within (Day 176) | 37 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - above (Day 176) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - within (Day 176) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - within (Day 176) | 34 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - within (Day 176) | 42 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - within (Day 176) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - within (Day 176) | 40 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - within (Day 176) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - within (Day 176) | 41 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - within (Day 176) | 29 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - within (Day 176) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - above (Day 176) | 6 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - above (Day 176) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - above (Day 176) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - within (Day 176) | 42 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - above (Day 176) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - within (Day 176) | 5 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - within (Day 176) | 25 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - above (Day 176) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - below (Day 176) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - below (Day 176) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - below (Day 176) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - below (Day 176) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - above (Day 176) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - above (Day 176) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - within (Day 176) | 35 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - within (Day 176) | 40 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - above (Day 176) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - below (Day 176) | 5 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - below (Day 176) | 7 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - above (Day 176) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - above (Day 176) | 5 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - above (Day 176) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - within (Day 176) | 7 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - within (Day 176) | 23 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - within (Day 176) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - above (Day 176) | 6 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - within (Day 176) | 39 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - within (Day 176) | 24 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - within (Day 176) | 34 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - within (Day 176) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - above (Day 176) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - within (Day 176) | 33 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - within (Day 176) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - below (Day 176) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - below (Day 176) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - within (Day 176) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - within (Day 176) | 33 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - below (Day 176) | 5 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - below (Day 176) | 5 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - within (Day 176) | 28 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - within (Day 176) | 38 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - within (Day 176) | 38 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - within (Day 176) | 28 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - within (Day 176) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - above (Day 176) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - above (Day 176) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - within (Day 176) | 36 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - within (Day 176) | 37 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - within (Day 176) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - within (Day 176) | 35 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - above (Day 176) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - within (Day 176) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - above (Day 176) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - above (Day 176) | 9 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - within (Day 176) | 36 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - above (Day 176) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - within (Day 176) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - within (Day 176) | 5 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - within (Day 176) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - above (Day 176) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Within (baseline) - below (Day 176) | 5 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Monocytes | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Blood Urea Nitrogen | Below (baseline) - below (Day 176) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - within (Day 176) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - within (Day 176) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Neutrophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Creatinine | Below (baseline) - below (Day 176) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - above (Day 176) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - within (Day 176) | 7 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - within (Day 176) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - within (Day 176) | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | ALT | Within (baseline) - within (Day 176) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Hemoglobin | Above (baseline) - above (Day 176) | 4 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Eosinophils | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Within (baseline) - within (Day 176) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - within (Day 176) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Within (baseline) - within (Day 176) | 11 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - within (Day 176) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Below (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | White Blood Cells [WBC] | Within (baseline) - within (Day 176) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Below (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Platelets | Above (baseline) - within (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Within (baseline) - above (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Basophils | Within (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | AST | Above (baseline) - below (Day 176) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176 | Lymphocytes | Above (baseline) - above (Day 176) | 0 Participants |
Primary
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 169 (baseline) and Day 197 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 197)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 197 (28 days after the third study intervention administration) compared to Baseline (Day 169)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - within (Day 197) | 42 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - within (Day 197) | 42 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - above (Day 197) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - below (Day 197) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - below (Day 197) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - within (Day 197) | 35 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - above (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - within (Day 197) | 42 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - below (Day 197) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - below (Day 197) | 9 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Within (baseline) - within (Day 197) | 41 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - below (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - within (Day 197) | 8 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - within (Day 197) | 21 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - within (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - above (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - within (Day 197) | 39 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - within (Day 197) | 33 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - above (Day 197) | 5 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - within (Day 197) | 38 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - within (Day 197) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - within (Day 197) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - within (Day 197) | 6 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - within (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - within (Day 197) | 28 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - within (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - above (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - within (Day 197) | 39 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - above (Day 197) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - below (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - below (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - within (Day 197) | 36 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - above (Day 197) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - within (Day 197) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - within (Day 197) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - above (Day 197) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - within (Day 197) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - within (Day 197) | 28 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - within (Day 197) | 5 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - above (Day 197) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Within (baseline) - within (Day 197) | 36 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Above (baseline) - within (Day 197) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Above (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - within (Day 197) | 30 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - within (Day 197) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - above (Day 197) | 6 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - within (Day 197) | 32 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - within (Day 197) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - above (Day 197) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - above (Day 197) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - below (Day 197) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - below (Day 197) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - within (Day 197) | 33 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - below (Day 197) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - below (Day 197) | 5 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - within (Day 197) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - within (Day 197) | 28 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - within (Day 197) | 38 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - within (Day 197) | 38 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - within (Day 197) | 29 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - within (Day 197) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - above (Day 197) | 6 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - within (Day 197) | 37 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - within (Day 197) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - within (Day 197) | 37 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - within (Day 197) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - below (Day 197) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - within (Day 197) | 33 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - within (Day 197) | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - within (Day 197) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - within (Day 197) | 6 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - within (Day 197) | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - within (Day 197) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - within (Day 197) | 11 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Hemoglobin | Above (baseline) - above (Day 197) | 4 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | ALT | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - within (Day 197) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Within (baseline) - within (Day 197) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - within (Day 197) | 9 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - within (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Within (baseline) - within (Day 197) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Within (baseline) - below (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Blood Urea Nitrogen | Below (baseline) - below (Day 197) | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - within (Day 197) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - within (Day 197) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Lymphocytes | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Within (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Neutrophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Basophils | Above (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Creatinine | Below (baseline) - below (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | White Blood Cells [WBC] | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Below (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Above (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Within (baseline) - above (Day 197) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Monocytes | Within (baseline) - below (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Below (baseline) - within (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Below (baseline) - above (Day 197) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Platelets | Above (baseline) - above (Day 197) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | Eosinophils | Within (baseline) - within (Day 197) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197 | AST | Above (baseline) - within (Day 197) | 0 Participants |
Primary
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 1 (baseline) and Day 29 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 29)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 29 (28 days after the first study intervention administration) compared to Baseline (Day 1)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - within (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - within (Day 29) | 44 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - within (Day 29) | 45 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - above (Day 29) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - above (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - below (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - within (Day 29) | 39 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - within (Day 29) | 38 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - within (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - within (Day 29) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - below (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - within (Day 29) | 45 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - above (Day 29) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - within (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - above (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - within (Day 29) | 35 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - within (Day 29) | 41 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - below (Day 29) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - within (Day 29) | 43 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - below (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - above (Day 29) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - within (Day 29) | 5 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - below (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - within (Day 29) | 41 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - above (Day 29) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - within (Day 29) | 44 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - below (Day 29) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - below (Day 29) | 8 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - within (Day 29) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - within (Day 29) | 8 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - below (Day 29) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - within (Day 29) | 25 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - within (Day 29) | 39 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - below (Day 29) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - below (Day 29) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - within (Day 29) | 31 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - within (Day 29) | 5 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - above (Day 29) | 6 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - above (Day 29) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - within (Day 29) | 41 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - above (Day 29) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - above (Day 29) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - below (Day 29) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - within (Day 29) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - within (Day 29) | 42 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - below (Day 29) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - below (Day 29) | 6 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - within (Day 29) | 9 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - within (Day 29) | 27 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - within (Day 29) | 44 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - within (Day 29) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - within (Day 29) | 45 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - within (Day 29) | 39 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - within (Day 29) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - above (Day 29) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - above (Day 29) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - within (Day 29) | 44 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - within (Day 29) | 45 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - within (Day 29) | 43 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - within (Day 29) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - above (Day 29) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - within (Day 29) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - within (Day 29) | 36 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - within (Day 29) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - above (Day 29) | 5 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - within (Day 29) | 43 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - within (Day 29) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - within (Day 29) | 8 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - within (Day 29) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - within (Day 29) | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - below (Day 29) | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - below (Day 29) | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - within (Day 29) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - within (Day 29) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - within (Day 29) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Monocytes | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - within (Day 29) | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Creatinine | Below (baseline) - below (Day 29) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - above (Day 29) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - above (Day 29) | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - within (Day 29) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Above (baseline) - within (Day 29) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - within (Day 29) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - within (Day 29) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - within (Day 29) | 11 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Eosinophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Neutrophils | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - within (Day 29) | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - within (Day 29) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Below (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Within (baseline) - above (Day 29) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - within (Day 29) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Hemoglobin | Above (baseline) - above (Day 29) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | White Blood Cells [WBC] | Within (baseline) - below (Day 29) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Basophils | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | ALT | Within (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Below (baseline) - within (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Above (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Platelets | Above (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Within (baseline) - within (Day 29) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Within (baseline) - above (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | AST | Below (baseline) - below (Day 29) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Lymphocytes | Above (baseline) - within (Day 29) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29 | Blood Urea Nitrogen | Below (baseline) - above (Day 29) | 0 Participants |
Primary
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 57 (baseline) and Day 64 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 64)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 64 (7 days after the second study intervention administration) compared to Baseline (Day 57)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - within (Day 64) | 43 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - within (Day 64) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - within (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - within (Day 64) | 44 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - within (Day 64) | 34 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - above (Day 64) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - within (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - above (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - above (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - within (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - within (Day 64) | 40 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - within (Day 64) | 37 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - within (Day 64) | 40 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - within (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - within (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - within (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - below (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - within (Day 64) | 40 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - above (Day 64) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - within (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - above (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - within (Day 64) | 44 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - below (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - above (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - above (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - above (Day 64) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - within (Day 64) | 38 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - above (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - below (Day 64) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - above (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - below (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - within (Day 64) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - within (Day 64) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - within (Day 64) | 41 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - within (Day 64) | 41 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - below (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - above (Day 64) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - below (Day 64) | 6 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - below (Day 64) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - above (Day 64) | 6 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - within (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - above (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - within (Day 64) | 9 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - below (Day 64) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - within (Day 64) | 26 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - above (Day 64) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - above (Day 64) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - within (Day 64) | 35 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - within (Day 64) | 41 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - below (Day 64) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - within (Day 64) | 35 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - within (Day 64) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - above (Day 64) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - above (Day 64) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - within (Day 64) | 39 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - within (Day 64) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - below (Day 64) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - below (Day 64) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - within (Day 64) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - within (Day 64) | 34 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - below (Day 64) | 5 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - below (Day 64) | 8 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - within (Day 64) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - within (Day 64) | 28 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - within (Day 64) | 43 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - within (Day 64) | 43 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - below (Day 64) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - within (Day 64) | 37 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - within (Day 64) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - above (Day 64) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - within (Day 64) | 42 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - above (Day 64) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - within (Day 64) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - above (Day 64) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - below (Day 64) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - within (Day 64) | 39 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - within (Day 64) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - above (Day 64) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - above (Day 64) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - above (Day 64) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - above (Day 64) | 5 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - within (Day 64) | 41 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - above (Day 64) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - within (Day 64) | 8 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - above (Day 64) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - within (Day 64) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - within (Day 64) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - below (Day 64) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - above (Day 64) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Below (baseline) - below (Day 64) | 4 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - above (Day 64) | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - within (Day 64) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - within (Day 64) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - within (Day 64) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Within (baseline) - within (Day 64) | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Creatinine | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - above (Day 64) | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - above (Day 64) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Neutrophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - within (Day 64) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - within (Day 64) | 11 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Eosinophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | ALT | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - within (Day 64) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Below (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - within (Day 64) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Hemoglobin | Above (baseline) - above (Day 64) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Monocytes | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Within (baseline) - within (Day 64) | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Within (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Basophils | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | White Blood Cells [WBC] | Within (baseline) - within (Day 64) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Below (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Above (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Platelets | Above (baseline) - within (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Within (baseline) - within (Day 64) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Blood Urea Nitrogen | Within (baseline) - above (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | AST | Below (baseline) - below (Day 64) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64 | Lymphocytes | Above (baseline) - within (Day 64) | 0 Participants |
Primary
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 1 (baseline) and Day 8 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 8)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 8 (7 days after the first study intervention administration) compared to Baseline (Day 1)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - below (Day 8) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - below (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - within (Day 8) | 38 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - above (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - above (Day 8) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - within (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - above (Day 8) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - within (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - above (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - above (Day 8) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - within (Day 8) | 41 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - above (Day 8) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - within (Day 8) | 44 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - above (Day 8) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - within (Day 8) | 36 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - below (Day 8) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - within (Day 8) | 43 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - above (Day 8) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - above (Day 8) | 6 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - below (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - above (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - above (Day 8) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - within (Day 8) | 39 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - above (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - within (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - within (Day 8) | 41 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - within (Day 8) | 41 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - within (Day 8) | 45 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - within (Day 8) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - below (Day 8) | 6 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - below (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - below (Day 8) | 11 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - within (Day 8) | 6 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - below (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - within (Day 8) | 22 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - within (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - above (Day 8) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - above (Day 8) | 5 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - within (Day 8) | 37 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - within (Day 8) | 35 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - above (Day 8) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - within (Day 8) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - within (Day 8) | 35 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - within (Day 8) | 5 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - above (Day 8) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - above (Day 8) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - within (Day 8) | 43 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - within (Day 8) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - below (Day 8) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - below (Day 8) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - within (Day 8) | 41 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - below (Day 8) | 5 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - below (Day 8) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - within (Day 8) | 7 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - within (Day 8) | 29 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - within (Day 8) | 39 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - within (Day 8) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - above (Day 8) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - above (Day 8) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - within (Day 8) | 43 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - above (Day 8) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - within (Day 8) | 44 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - above (Day 8) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - within (Day 8) | 42 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - within (Day 8) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - above (Day 8) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - above (Day 8) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - within (Day 8) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - within (Day 8) | 32 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - within (Day 8) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - above (Day 8) | 5 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - above (Day 8) | 6 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - below (Day 8) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - within (Day 8) | 44 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - within (Day 8) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - within (Day 8) | 45 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - below (Day 8) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - within (Day 8) | 41 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - within (Day 8) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - above (Day 8) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - below (Day 8) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - within (Day 8) | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - within (Day 8) | 11 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - within (Day 8) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Within (baseline) - above (Day 8) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - within (Day 8) | 11 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Above (baseline) - above (Day 8) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - within (Day 8) | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Blood Urea Nitrogen | Below (baseline) - below (Day 8) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - within (Day 8) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - within (Day 8) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - within (Day 8) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - within (Day 8) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - within (Day 8) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Basophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Within (baseline) - below (Day 8) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - within (Day 8) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Creatinine | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - within (Day 8) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - within (Day 8) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Monocytes | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Lymphocytes | Below (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - above (Day 8) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - above (Day 8) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Within (baseline) - within (Day 8) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - within (Day 8) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | White Blood Cells [WBC] | Above (baseline) - within (Day 8) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Below (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Within (baseline) - within (Day 8) | 11 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Eosinophils | Above (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Within (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Below (baseline) - within (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | AST | Above (baseline) - within (Day 8) | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Neutrophils | Above (baseline) - above (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Hemoglobin | Above (baseline) - below (Day 8) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | ALT | Above (baseline) - within (Day 8) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8 | Platelets | Below (baseline) - below (Day 8) | 0 Participants |
Primary
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 57 (baseline) and Day 85 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 85)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 85 (28 days after the second study intervention administration) compared to Baseline (Day 57)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - within (Day 85) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - within (Day 85) | 40 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - above (Day 85) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - within (Day 85) | 42 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - within (Day 85) | 43 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - below (Day 85) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - within (Day 85) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - within (Day 85) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - within (Day 85) | 43 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - within (Day 85) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - above (Day 85) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - within (Day 85) | 33 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - above (Day 85) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - above (Day 85) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - above (Day 85) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - within (Day 85) | 41 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - below (Day 85) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - within (Day 85) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - within (Day 85) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - above (Day 85) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - within (Day 85) | 36 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - within (Day 85) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - below (Day 85) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - above (Day 85) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - below (Day 85) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - below (Day 85) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - below (Day 85) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - below (Day 85) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - above (Day 85) | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - above (Day 85) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - within (Day 85) | 39 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - within (Day 85) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - above (Day 85) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - within (Day 85) | 41 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - below (Day 85) | 9 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - below (Day 85) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - above (Day 85) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - within (Day 85) | 1 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - within (Day 85) | 6 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - within (Day 85) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - within (Day 85) | 27 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - above (Day 85) | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - within (Day 85) | 44 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - within (Day 85) | 39 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - within (Day 85) | 37 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - below (Day 85) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - within (Day 85) | 33 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - within (Day 85) | 6 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - above (Day 85) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - within (Day 85) | 36 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - within (Day 85) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - above (Day 85) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - above (Day 85) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - below (Day 85) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - below (Day 85) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - within (Day 85) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - within (Day 85) | 35 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - below (Day 85) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - below (Day 85) | 6 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - within (Day 85) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - within (Day 85) | 30 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - within (Day 85) | 43 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - within (Day 85) | 43 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - within (Day 85) | 38 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - within (Day 85) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - above (Day 85) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - within (Day 85) | 42 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - above (Day 85) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - within (Day 85) | 42 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - above (Day 85) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - within (Day 85) | 41 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - within (Day 85) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - above (Day 85) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - within (Day 85) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - above (Day 85) | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - above (Day 85) | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - within (Day 85) | 43 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - within (Day 85) | 8 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - within (Day 85) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - within (Day 85) | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - above (Day 85) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Within (baseline) - below (Day 85) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Monocytes | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Blood Urea Nitrogen | Below (baseline) - below (Day 85) | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - within (Day 85) | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - within (Day 85) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - within (Day 85) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Within (baseline) - below (Day 85) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Above (baseline) - within (Day 85) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Neutrophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Creatinine | Below (baseline) - below (Day 85) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - above (Day 85) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - within (Day 85) | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - within (Day 85) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | ALT | Within (baseline) - within (Day 85) | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Within (baseline) - above (Day 85) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Hemoglobin | Above (baseline) - above (Day 85) | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Eosinophils | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - within (Day 85) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Within (baseline) - within (Day 85) | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Within (baseline) - within (Day 85) | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - within (Day 85) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - within (Day 85) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Below (baseline) - within (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | White Blood Cells [WBC] | Within (baseline) - within (Day 85) | 15 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Below (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Platelets | Above (baseline) - within (Day 85) | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Within (baseline) - above (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Basophils | Within (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | AST | Above (baseline) - below (Day 85) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85 | Lymphocytes | Above (baseline) - above (Day 85) | 0 Participants |
Primary
Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration
The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature \>=38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade.
Time frame: Within 7 days post vaccination (day of administration and 6 subsequent days post-second vaccination on Day 57)
Population: The analysis was performed on the Solicited safety set, which included all participants who received second dose of the study intervention and who had solicited safety data in the 7 days following second intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration | Myalgia | 18 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration | Headache | 22 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration | Arthralgia | 11 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration | Fatigue | 18 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration | Fever | 5 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration | Headache | 26 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration | Arthralgia | 11 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration | Fatigue | 24 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration | Myalgia | 20 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration | Fever | 5 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration | Fever | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration | Myalgia | 5 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration | Arthralgia | 5 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration | Headache | 5 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration | Fatigue | 4 Participants |
Secondary
Stage 1 and Stage 2: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study
Any AEs including SAEs that lead to withdrawal from the study are considered under this outcome measure. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.
Time frame: From 28 days after the third study intervention administration (Day 197) up to study end (Day 337)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1 and Stage 2: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1 and Stage 2: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1 and Stage 2: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1 and Stage 2: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | 0 Participants |
| Stage 1: Placebo Group | Stage 1 and Stage 2: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | 0 Participants |
| Stage 2: iNTS-TCV Full Dose Group | Stage 1 and Stage 2: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | 0 Participants |
| Stage 2: iNTS-GMMA + TCV Full Dose Group | Stage 1 and Stage 2: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | 0 Participants |
| Stage 2: Control Group | Stage 1 and Stage 2: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study | 0 Participants |
Secondary
Stage 1 and Stage 2: Number of Participants With Any 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, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade.
Time frame: From 28 days after the third study intervention administration (Day 197) up to study end (Day 337)
Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1 and Stage 2: Number of Participants With Any SAEs | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1 and Stage 2: Number of Participants With Any SAEs | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1 and Stage 2: Number of Participants With Any SAEs | 0 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1 and Stage 2: Number of Participants With Any SAEs | 0 Participants |
| Stage 1: Placebo Group | Stage 1 and Stage 2: Number of Participants With Any SAEs | 0 Participants |
| Stage 2: iNTS-TCV Full Dose Group | Stage 1 and Stage 2: Number of Participants With Any SAEs | 0 Participants |
| Stage 2: iNTS-GMMA + TCV Full Dose Group | Stage 1 and Stage 2: Number of Participants With Any SAEs | 1 Participants |
| Stage 2: Control Group | Stage 1 and Stage 2: Number of Participants With Any SAEs | 1 Participants |
Secondary
Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG
Anti-Vi antigen (Ag) total IgG GMCs were assessed. Blood samples were collected at specified timepoint for each component as measured by Enzyme-Linked Immunosorbent Assay (ELISA). The lower limit of quantification (LLOQ) for antibody concentrations was \>=2.2 microgram per milliliter (µg/mL). In case the measured antibody concentration fell below 2.2 µg/mL, a value of half the LLOQ value was imputed.
Time frame: At Days 1, 57, and 169 (before each study intervention administration) and at Days 29, 85, and 197 (28 days after each study intervention administration)
Population: The analysis was performed on the Per Protocol Set (PPS), that included all eligible participants who received all doses as per protocol, had immunogenicity results post-dose, complied with dosing/blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 1 | 1.10 microgram per milliliter (µg/mL) |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 29 | 30.29 microgram per milliliter (µg/mL) |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 57 | 23.28 microgram per milliliter (µg/mL) |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 85 | 30.52 microgram per milliliter (µg/mL) |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 169 | 13.61 microgram per milliliter (µg/mL) |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 197 | 20.19 microgram per milliliter (µg/mL) |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 169 | 14.11 microgram per milliliter (µg/mL) |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 197 | 17.43 microgram per milliliter (µg/mL) |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 1 | 1.10 microgram per milliliter (µg/mL) |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 57 | 53.95 microgram per milliliter (µg/mL) |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 85 | 51.71 microgram per milliliter (µg/mL) |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 29 | 68.87 microgram per milliliter (µg/mL) |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 85 | 34.02 microgram per milliliter (µg/mL) |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 169 | 15.76 microgram per milliliter (µg/mL) |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 1 | 1.10 microgram per milliliter (µg/mL) |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 57 | 25.99 microgram per milliliter (µg/mL) |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 29 | 43.55 microgram per milliliter (µg/mL) |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 197 | 31.84 microgram per milliliter (µg/mL) |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 85 | 51.65 microgram per milliliter (µg/mL) |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 29 | 66.48 microgram per milliliter (µg/mL) |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 57 | 51.01 microgram per milliliter (µg/mL) |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 197 | 35.24 microgram per milliliter (µg/mL) |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 169 | 20.69 microgram per milliliter (µg/mL) |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 1 | 1.10 microgram per milliliter (µg/mL) |
| Stage 1: Placebo Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 169 | 1.10 microgram per milliliter (µg/mL) |
| Stage 1: Placebo Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 57 | 1.10 microgram per milliliter (µg/mL) |
| Stage 1: Placebo Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 29 | 1.10 microgram per milliliter (µg/mL) |
| Stage 1: Placebo Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 197 | 1.10 microgram per milliliter (µg/mL) |
| Stage 1: Placebo Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 85 | 1.10 microgram per milliliter (µg/mL) |
| Stage 1: Placebo Group | Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG | Anti-Vi Ag total IgG, Day 1 | 1.10 microgram per milliliter (µg/mL) |
Comparison: Anti-Vi Ag IgG, Day 2995% CI: [0.06, 3.43]ANOVA
Comparison: Anti-Vi Ag IgG, Day 2995% CI: [0.25, 1.7]ANOVA
Comparison: Anti-Vi Ag IgG, Day 5795% CI: [0.06, 2.94]ANOVA
Comparison: Anti-Vi Ag IgG, Day 5795% CI: [0.19, 1.37]ANOVA
Comparison: Anti-Vi Ag IgG, Day 8595% CI: [0.13, 2.65]ANOVA
Comparison: Anti-Vi Ag IgG, Day 8595% CI: [0.3, 1.43]ANOVA
Comparison: Anti-Vi Ag IgG, Day 16995% CI: [0.18, 5.12]ANOVA
Comparison: Anti-Vi Ag IgG, Day 16995% CI: [0.36, 1.6]ANOVA
Comparison: Anti-Vi Ag IgG, Day 19795% CI: [0.23, 5.79]ANOVA
Comparison: Anti-Vi Ag IgG, Day 19795% CI: [0.44, 1.84]ANOVA
Secondary
Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-Vi antigen (Ag) total IgG, Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG within-participant GMRs were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint.
Time frame: At 28 days after each study intervention administration compared to each study intervention administration baseline (Day 29 versus Day 1, Day 85 versus Day 57 and Day 197 versus Day 169)
Population: The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 197 | 1.29 Ratio |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 85 | 0.97 Ratio |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 85 | 1.31 Ratio |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 197 | 1.47 Ratio |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 85 | 1.06 Ratio |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 197 | 1.96 Ratio |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 29 | 13.57 Ratio |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 29 | 24.42 Ratio |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 29 | 27.53 Ratio |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 29 | 3.96 Ratio |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 197 | 1.49 Ratio |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 29 | 3.42 Ratio |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 85 | 1.74 Ratio |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 197 | 1.24 Ratio |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 197 | 1.93 Ratio |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 85 | 0.96 Ratio |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 29 | 62.61 Ratio |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 85 | 1.48 Ratio |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 197 | 1.20 Ratio |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 29 | 39.60 Ratio |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 85 | 1.31 Ratio |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 197 | 1.99 Ratio |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 29 | 15.15 Ratio |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 85 | 1.05 Ratio |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 29 | 13.12 Ratio |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 85 | 0.99 Ratio |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 197 | 1.15 Ratio |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 29 | 12.14 Ratio |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 197 | 1.24 Ratio |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 197 | 1.70 Ratio |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 29 | 11.98 Ratio |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 85 | 1.01 Ratio |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 197 | 1.17 Ratio |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 85 | 1.18 Ratio |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 29 | 60.44 Ratio |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 85 | 1.23 Ratio |
| Stage 1: Placebo Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 29 | 1.00 Ratio |
| Stage 1: Placebo Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 29 | 1.01 Ratio |
| Stage 1: Placebo Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 197 | 0.97 Ratio |
| Stage 1: Placebo Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 197 | 1.00 Ratio |
| Stage 1: Placebo Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 85 | 1.17 Ratio |
| Stage 1: Placebo Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 197 | 0.97 Ratio |
| Stage 1: Placebo Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 85 | 1.22 Ratio |
| Stage 1: Placebo Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 29 | 0.99 Ratio |
| Stage 1: Placebo Group | Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 85 | 1.00 Ratio |
Secondary
Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG GMCs were assessed. Blood samples were collected at specified timepoint for each component as measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Time frame: At Days 1, 57, and 169 (before each study intervention administration) and at Days 29, 85, and 197 (28 days after each study intervention administration)
Population: The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 29 | 920.64 ELISA units per milliliter (EU/mL) |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 169 | 557.81 ELISA units per milliliter (EU/mL) |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 1 | 20.25 ELISA units per milliliter (EU/mL) |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 85 | 410.29 ELISA units per milliliter (EU/mL) |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 197 | 249.07 ELISA units per milliliter (EU/mL) |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 197 | 451.36 ELISA units per milliliter (EU/mL) |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 85 | 882.68 ELISA units per milliliter (EU/mL) |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 57 | 423.33 ELISA units per milliliter (EU/mL) |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 169 | 272.19 ELISA units per milliliter (EU/mL) |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 1 | 67.85 ELISA units per milliliter (EU/mL) |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 29 | 494.50 ELISA units per milliliter (EU/mL) |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 57 | 832.83 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 197 | 81.17 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 197 | 163.07 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 29 | 169.25 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 1 | 42.77 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 1 | 49.45 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 169 | 42.14 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 57 | 139.78 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 29 | 169.46 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 85 | 209.03 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 85 | 243.42 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 57 | 141.59 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 169 | 109.20 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 169 | 903.37 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 1 | 94.10 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 29 | 1426.07 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 57 | 1075.57 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 85 | 1129.27 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 169 | 703.74 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 197 | 1005.05 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 1 | 125.64 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 29 | 1648.46 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 57 | 1454.26 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 85 | 1436.56 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 197 | 1168.56 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 197 | 1176.88 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 1 | 124.02 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 29 | 1387.16 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 169 | 951.71 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 57 | 1076.32 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 85 | 1478.01 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 197 | 855.62 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 85 | 1267.65 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 57 | 1203.79 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 29 | 1505.55 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 169 | 729.86 ELISA units per milliliter (EU/mL) |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 1 | 115.74 ELISA units per milliliter (EU/mL) |
| Stage 1: Placebo Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 197 | 73.43 ELISA units per milliliter (EU/mL) |
| Stage 1: Placebo Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 85 | 79.79 ELISA units per milliliter (EU/mL) |
| Stage 1: Placebo Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 1 | 52.23 ELISA units per milliliter (EU/mL) |
| Stage 1: Placebo Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 29 | 56.62 ELISA units per milliliter (EU/mL) |
| Stage 1: Placebo Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 29 | 52.86 ELISA units per milliliter (EU/mL) |
| Stage 1: Placebo Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 85 | 68.07 ELISA units per milliliter (EU/mL) |
| Stage 1: Placebo Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 197 | 73.74 ELISA units per milliliter (EU/mL) |
| Stage 1: Placebo Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 169 | 75.80 ELISA units per milliliter (EU/mL) |
| Stage 1: Placebo Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 57 | 65.49 ELISA units per milliliter (EU/mL) |
| Stage 1: Placebo Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 1 | 57.08 ELISA units per milliliter (EU/mL) |
| Stage 1: Placebo Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 57 | 58.38 ELISA units per milliliter (EU/mL) |
| Stage 1: Placebo Group | Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 169 | 75.96 ELISA units per milliliter (EU/mL) |
Comparison: Anti-S.Typhimurium OAg IgG Day 2995% CI: [0.48, 17.8]ANOVA
Comparison: Anti-S.Typhimurium OAg IgG Day 2995% CI: [0.41, 2.19]ANOVA
Comparison: Anti-S.Typhimurium OAg IgG Day 5795% CI: [0.43, 21.45]ANOVA
Comparison: Anti-S.Typhimurium OAg IgG Day 5795% CI: [0.33, 2.45]ANOVA
Comparison: Anti-S.Typhimurium OAg IgG Day 8595% CI: [0.26, 10.96]ANOVA
Comparison: Anti-S.Typhimurium OAg IgG Day 8595% CI: [0.29, 2]ANOVA
Comparison: Anti-S.Typhimurium OAg IgG Day 16995% CI: [0.24, 26.3]ANOVA
Comparison: Anti-S.Typhimurium OAg IgG Day 16995% CI: [0.26, 2.11]ANOVA
Comparison: Anti-S.Typhimurium OAg IgG Day 19795% CI: [0.19, 12.41]ANOVA
Comparison: Anti-S.Typhimurium OAg IgG Day 19795% CI: [0.34, 2.15]ANOVA
Comparison: Anti-S.Enteritidis OAg IgG Day 2995% CI: [0.61, 48.17]ANOVA
Comparison: Anti-S.Enteritidis OAg IgG Day 2995% CI: [0.43, 3.26]ANOVA
Comparison: Anti-S.Enteritidis OAg IgG Day 5795% CI: [0.58, 59.45]ANOVA
Comparison: Anti-S.Enteritidis OAg IgG Day 5795% CI: [0.41, 4.45]ANOVA
Comparison: Anti-S.Enteritidis OAg IgG Day 8595% CI: [0.48, 37.19]ANOVA
Comparison: Anti-S.Enteritidis OAg IgG Day 8595% CI: [0.37, 3.48]ANOVA
Comparison: Anti-S.Enteritidis OAg IgG Day 16995% CI: [1.02, 172.55]ANOVA
Comparison: Anti-S.Enteritidis OAg IgG Day 16995% CI: [0.4, 3.88]ANOVA
Comparison: Anti-S.Enteritidis OAg IgG Day 19795% CI: [0.53, 58.61]ANOVA
Comparison: Anti-S.Enteritidis OAg IgG Day 19795% CI: [0.48, 3.86]ANOVA
Secondary
Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-Vi Ag total IgG, Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG antibody concentrations were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA.
Time frame: At Days 29, 85, and 197 (28 days after each study intervention administration) compared to Day 1 (first study intervention administration)
Population: The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 197 | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 85 | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 85 | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 197 | 3 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 85 | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 197 | 2 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 29 | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 29 | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 29 | 4 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 29 | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 197 | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 29 | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 85 | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 197 | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 197 | 1 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 85 | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 29 | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 85 | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 197 | 6 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 29 | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 85 | 10 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 197 | 10 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 29 | 13 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 85 | 8 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 29 | 11 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 85 | 7 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 197 | 4 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 29 | 15 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 197 | 10 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 197 | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 29 | 12 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 85 | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 197 | 10 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 85 | 11 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 29 | 16 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 85 | 14 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 29 | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 29 | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 197 | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 197 | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 85 | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 197 | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 85 | 1 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 29 | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 85 | 0 Participants |
Secondary
Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL)
Blood samples were collected at specified timepoint for each component as measured by ELISA.
Time frame: At Days 1, 57 and 169 (before each study intervention administration) and at Days 29, 85 and 197 (28 days after each study intervention administration)
Population: The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 1 (pre-Dose 1) | 0 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 29 | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 57 (pre-Dose 2) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 85 | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 169 (pre-Dose 3) | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 197 | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 169 (pre-Dose 3) | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 197 | 2 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 1 (pre-Dose 1) | 0 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 57 (pre-Dose 2) | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 85 | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 29 | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 85 | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 169 (pre-Dose 3) | 11 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 1 (pre-Dose 1) | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 57 (pre-Dose 2) | 9 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 29 | 14 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 197 | 11 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 85 | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 29 | 16 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 57 (pre-Dose 2) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 197 | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 169 (pre-Dose 3) | 14 Participants |
| Stage 1: iNTS-GMMA + TCV Full Dose Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 1 (pre-Dose 1) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 169 (pre-Dose 3) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 57 (pre-Dose 2) | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 29 | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 197 | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 85 | 0 Participants |
| Stage 1: Placebo Group | Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL) | Day 1 (pre-Dose 1) | 0 Participants |
Secondary
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S. Typhimurium OAg total IgG and Anti-S. Enteritidis OAg total IgG GMCs and between group ratios were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA.
Time frame: At Days 1, 57, and 169 (before each study intervention administration) and at Days 29, 85, and 197 (28 days after each study intervention administration)
Population: The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 1 | 246.02 EU/mL |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 29 | 1591.68 EU/mL |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 57 | 1159.50 EU/mL |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 85 | 1102.67 EU/mL |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 169 | 870.80 EU/mL |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 197 | 992.82 EU/mL |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 1 | 363.08 EU/mL |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 29 | 1884.94 EU/mL |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 57 | 1527.50 EU/mL |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 85 | 1604.28 EU/mL |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 169 | 946.93 EU/mL |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 197 | 1093.84 EU/mL |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 197 | 1327.68 EU/mL |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 1 | 490.94 EU/mL |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 1 | 376.17 EU/mL |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 57 | 1581.75 EU/mL |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 29 | 2585.81 EU/mL |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 197 | 1748.80 EU/mL |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 169 | 1015.74 EU/mL |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 57 | 1794.69 EU/mL |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 29 | 2295.38 EU/mL |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 169 | 1248.95 EU/mL |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 85 | 1765.79 EU/mL |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 85 | 1555.91 EU/mL |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 85 | 545.05 EU/mL |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 169 | 565.73 EU/mL |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 85 | 456.04 EU/mL |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 197 | 542.87 EU/mL |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 1 | 394.19 EU/mL |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 29 | 457.08 EU/mL |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 169 | 408.69 EU/mL |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 1 | 392.99 EU/mL |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 29 | 446.22 EU/mL |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 57 | 470.88 EU/mL |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Typhimurium OAg IgG, Day 57 | 483.46 EU/mL |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG | Anti-S.Enteritidis OAg IgG, Day 197 | 423.08 EU/mL |
Comparison: Anti-S.Typhimurium OAg IgG Day 2995% CI: [0.69, 1.32]Mixed Models Analysis
Comparison: Anti-S.Typhimurium OAg IgG Day 5795% CI: [0.74, 1.37]Mixed Models Analysis
Comparison: Anti-S.Typhimurium OAg IgG Day 8595% CI: [0.77, 1.41]Mixed Models Analysis
Comparison: Anti-S.Typhimurium OAg IgG Day 16995% CI: [0.81, 1.77]Mixed Models Analysis
Comparison: Anti-S.Typhimurium OAg IgG Day 19795% CI: [0.65, 1.44]Mixed Models Analysis
Comparison: Anti-S.Enteritidis OAg IgG Day 2995% CI: [0.49, 1.37]ANOVA
Comparison: Anti-S.Enteritidis OAg IgG Day 5795% CI: [0.59, 1.59]ANOVA
Comparison: Anti-S.Enteritidis OAg IgG Day 8595% CI: [0.64, 1.67]ANOVA
Comparison: Anti-S.Enteritidis OAg IgG Day 16995% CI: [0.56, 1.54]ANOVA
Comparison: Anti-S.Enteritidis OAg IgG Day 19795% CI: [0.51, 1.33]ANOVA
Secondary
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG
Anti-Vi Ag total IgG GMCs and between group ratios were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA.
Time frame: At Days 1, 57, and 169 (before each study intervention administration) and at Days 29, 85, and 197 (28 days after each study intervention administration)
Population: The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | Anti-Vi Ag total IgG, Day 1 | 1.43 µg/mL |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | Anti-Vi Ag total IgG, Day 29 | 148.98 µg/mL |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | Anti-Vi Ag total IgG, Day 57 | 96.93 µg/mL |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | Anti-Vi Ag total IgG, Day 85 | 96.94 µg/mL |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | Anti-Vi Ag total IgG, Day 169 | 41.83 µg/mL |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | Anti-Vi Ag total IgG, Day 197 | 65.43 µg/mL |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | Anti-Vi Ag total IgG, Day 197 | 69.82 µg/mL |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | Anti-Vi Ag total IgG, Day 1 | 1.38 µg/mL |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | Anti-Vi Ag total IgG, Day 85 | 101.92 µg/mL |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | Anti-Vi Ag total IgG, Day 169 | 53.65 µg/mL |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | Anti-Vi Ag total IgG, Day 29 | 161.68 µg/mL |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | Anti-Vi Ag total IgG, Day 57 | 104.38 µg/mL |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | Anti-Vi Ag total IgG, Day 29 | 1.55 µg/mL |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | Anti-Vi Ag total IgG, Day 57 | 1.60 µg/mL |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | Anti-Vi Ag total IgG, Day 197 | 18.60 µg/mL |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | Anti-Vi Ag total IgG, Day 85 | 1.65 µg/mL |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | Anti-Vi Ag total IgG, Day 1 | 1.56 µg/mL |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG | Anti-Vi Ag total IgG, Day 169 | 1.88 µg/mL |
Comparison: Anti-Vi Ag IgG Day 2995% CI: [0.54, 1.58]ANOVA
Comparison: Anti-Vi Ag IgG Day 5795% CI: [0.54, 1.59]ANOVA
Comparison: Anti-Vi Ag IgG Day 8595% CI: [0.61, 1.49]ANOVA
Comparison: Anti-Vi Ag IgG Day 16995% CI: [0.45, 1.34]ANOVA
Comparison: Anti-Vi Ag IgG Day 19795% CI: [0.63, 1.4]ANOVA
Secondary
Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-Vi antigen (Ag) total IgG, Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG within-participant GMRs were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint.
Time frame: At 28 days after each study intervention administration compared to each study intervention administration baseline (Day 29 versus Day 1, Day 85 versus Day 57 and Day 197 versus Day 169)
Population: The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 29 | 6.47 Ratio |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 197 | 1.16 Ratio |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 197 | 1.14 Ratio |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 85 | 1.00 Ratio |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 29 | 104.51 Ratio |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 85 | 1.04 Ratio |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 197 | 1.56 Ratio |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 85 | 1.05 Ratio |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 29 | 5.19 Ratio |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 85 | 0.97 Ratio |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 29 | 116.84 Ratio |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 85 | 0.91 Ratio |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 197 | 1.37 Ratio |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 29 | 5.27 Ratio |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 197 | 1.41 Ratio |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 29 | 6.10 Ratio |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 85 | 0.99 Ratio |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 197 | 1.34 Ratio |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 197 | 9.89 Ratio |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 29 | 1.00 Ratio |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 29 | 1.16 Ratio |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-Vi Ag total IgG, Day 85 | 1.03 Ratio |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 197 | 1.04 Ratio |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 85 | 1.13 Ratio |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 29 | 1.14 Ratio |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Enteritidis OAg IgG Day 85 | 0.97 Ratio |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations | Anti-S.Typhimurium OAg IgG. Day 197 | 0.96 Ratio |
Secondary
Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-Vi Ag total IgG, Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG antibody concentrations were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA.
Time frame: At Days 29, 85, and 197 (28 days after each study intervention administration) compared to Day 1 (first study intervention administration baseline)
Population: The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 29 | 33 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 197 | 17 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, 197 | 23 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 85 | 22 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 29 | 44 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 85 | 21 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 197 | 41 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 85 | 44 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, 29 | 23 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 85 | 16 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 29 | 43 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 85 | 42 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 197 | 37 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 29 | 27 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, 197 | 16 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, 29 | 27 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 85 | 18 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 197 | 16 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 197 | 9 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 29 | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, 29 | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-Vi Ag IgG, Day 85 | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 197 | 0 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 85 | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, Day 29 | 1 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Enteritidis OAg IgG, Day 85 | 2 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag) | Anti-S.Typhimurium OAg IgG, 197 | 1 Participants |
Secondary
Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL
Blood samples were collected at specified timepoint for each component as measured by ELISA.
Time frame: At Days 1, 57 and 169 (before each study intervention administration) and at Days 29, 85 and 197 (28 days after each study intervention administration)
Population: The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | Day 29 | 45 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | Day 1 | 4 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | Day 57 | 45 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | Day 85 | 44 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | Day 169 | 41 Participants |
| Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group | Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | Day 197 | 41 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | Day 197 | 37 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | Day 85 | 43 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | Day 169 | 37 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | Day 1 | 3 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | Day 29 | 44 Participants |
| Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group | Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | Day 57 | 44 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | Day 29 | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | Day 57 | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | Day 197 | 12 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | Day 85 | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | Day 1 | 3 Participants |
| Stage 1: iNTS-TCV Full Dose Group | Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL | Day 169 | 3 Participants |