A Phase 1/2a, Observer-blind, Randomized, Controlled, Two-stage, Multi-country Study to Evaluate the Safety, Reactogenicity, and Immune Response of the Trivalent Vaccine Against Invasive Nontyphoidal Salmonella (iNTS) and Typhoid Fever in Healthy European and African Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Data will be collected in an observer-blind manner.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) low dose (Biological)
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.
干预措施: Saline (Other)
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.
干预措施: Invasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) low dose (Biological)
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.
干预措施: Typhoid conjugate vaccine (TCV) low dose (Biological)
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.
干预措施: Invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) full dose (Biological)
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.
干预措施: Saline (Other)
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.
干预措施: Invasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) full dose (Biological)
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.
干预措施: Typhoid conjugate vaccine (TCV) full dose (Biological)
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.
干预措施: Placebo (Drug)
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.
干预措施: Saline (Other)
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.
干预措施: Invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) full dose (Biological)
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.
干预措施: Saline (Other)
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.
干预措施: Invasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) full dose (Biological)
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.
干预措施: Typhoid conjugate vaccine (TCV) full dose (Biological)
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.
干预措施: GSK's Meningococcal A, C, Y and W-135 conjugate vaccine (Biological)
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.
干预措施: GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Combination Product)
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.
干预措施: Sanofi Pasteur's Typhoid Vi polysaccharide vaccine (Combination Product)
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.
干预措施: Saline (Other)
结局指标
主要结局
Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration
时间窗: 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
时间窗: 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 Administration Site Events After the First Study Intervention Administration
时间窗: 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
时间窗: 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
时间窗: 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 Third Study Intervention Administration
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
时间窗: 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 Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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 Systemic Events After the First Study Intervention Administration
时间窗: 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
时间窗: 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.
Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
时间窗: 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.
次要结局
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))