OUTCOMES |
Type of outcome
|
Outcome
|
Timepoint(s) at which outcome measured
|
Primary Outcome |
Outcome measure 1 - Number of participants in Europe/Stage 1 with solicited administration site events after the first study intervention administration. The solicited administration site events are pain, redness, and swelling.
|
During 7 days after the first study intervention administration occurring at Day 1 |
Primary Outcome |
Outcome measure 2 - Number of participants in Europe/Stage 1 with solicited administration site events after the second study intervention administration. The solicited administration site events are pain, redness, and swelling.
|
During 7 days after the second study intervention administration occurring at Day 57 |
Primary Outcome |
Outcome measure 3 - Number of participants in Europe/Stage 1 with solicited administration site events after the third study intervention administration. The solicited administration site events are pain, redness, and swelling.
|
During 7 days after the third study intervention administration occurring at Day 169 |
Primary Outcome |
Outcome measure 4 - Number of participants in Europe/Stage 1 with solicited systemic events after the first study intervention administration. The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature equal to or above (≥) 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F). The preferred location for measuring temperature is the axilla. |
During 7 days after the first study intervention administration occurring at Day 1 |
Primary Outcome |
Outcome measure 5 - Number of participants in Europe/Stage 1 with solicited systemic events after the second study intervention administration. The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla.
|
During 7 days after the second study intervention administration occurring at Day 57 |
Primary Outcome |
Outcome measure 6 - Number of participants in Europe/Stage 1 with solicited systemic events after the third study intervention administration. The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla.
|
During 7 days after the third study intervention administration occurring at Day 169 |
Primary Outcome |
Outcome measure 7 - Number of participants in Europe/Stage 1 with unsolicited adverse events (AEs) 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.
|
During 28 days after the first study intervention administration occurring at Day 1 |
Primary Outcome |
Outcome measure 8 - Number of participants in Europe/Stage 1 with unsolicited adverse events (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.
|
During 28 days after the second study intervention administration occurring at Day 57 |
Primary Outcome |
Outcome measure 9 - Number of participants in Europe/Stage 1 with unsolicited adverse events (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.
|
During 28 days after the third study intervention administration occurring at Day 169 |
Primary Outcome |
Outcome measure 10 - Number of participants in Europe/Stage 1 with serious adverse events (SAE). 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, represents a congenital anomaly/birth defect in the offspring of a study participant or abnormal pregnancy outcomes.
|
From first study intervention administration /Day 1/ up to 28 days after the third study intervention administration /Day 197/ |
Primary Outcome |
Outcome measure 11 - Number of participants in Europe/Stage 1 with AEs/SAEs leading to withdrawal from the study and/or withholding doses of study intervention. Any AEs including SAEs that leads to discontinuation of study intervention and/or the study is considered under this outcome measure.
|
From first study intervention administration /Day 17/ up to 28 days after the third study intervention administration /Day 197/ |
Primary Outcome |
Outcome measure 12 - Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 8. Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
|
At Day 8 - 7 days after the first study intervention administration |
Primary Outcome |
Outcome measure 13 - Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 64. Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
|
At Day 64 - 7 days after the second study intervention administration |
Primary Outcome |
Outcome measure 14 - Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 176. Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
|
At Day 176 - 7 days after the third study intervention administration |
Primary Outcome |
Outcome measure 15 - Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 2. Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
|
At Day 29 - 28 days after the first study intervention administration |
Primary Outcome |
Outcome measure 16 - Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 85. Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
|
At Day 85 - 28 days after the second study intervention administration |
Primary Outcome |
Outcome measure 17 - Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 197. Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
|
At Day 197 - 28 days after the third study intervention administration |
Primary Outcome |
Outcome measure 18 - Number of participants in Africa/Stage 2 with solicited administration site events after the first study intervention administration. The solicited administration site events are pain, redness, and swelling.
|
During 7 days after the first study intervention administration occurring at Day 1 |
Primary Outcome |
Outcome measure 19 - Number of participants in Africa/Stage 2 with solicited administration site events after the second study intervention administration. The solicited administration site events are pain, redness, and swelling.
|
During 7 days after the second study intervention administration occurring at Day 57 |
Primary Outcome |
Outcome measure 20 - Number of participants in Africa/Stage 2 with solicited administration site events after the third study intervention administration. The solicited administration site events are pain, redness, and swelling.
|
During 7 days after the third study intervention administration occurring at Day 169 |
Primary Outcome |
Outcome measure 21 - Number of participants in Africa/Stage 2 with solicited systemic events after the first study intervention administration. The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla.
|
During 7 days after the first study intervention administration occurring at Day 1 |
Primary Outcome |
Outcome measure 22 - Number of participants in Africa/Stage 2 with solicited systemic events after the second study intervention administration. The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla.
|
During 7 days after the second study intervention administration occurring at Day 57 |
Primary Outcome |
Outcome measure 23 - Number of participants in Africa/Stage 2 with solicited systemic events after the third study intervention administration. The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla.
|
During 7 days after the third study intervention administration occurring at Day 169 |
Primary Outcome |
Outcome measure 24 - Number of participants in Africa/Stage 2 with unsolicited adverse events (AEs) 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.
|
During 28 days after the first study intervention administration occurring at Day 1 |
Primary Outcome |
Outcome measure 25 - Number of participants in Africa/Stage 2 with unsolicited adverse events (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.
|
During 28 days after the second study intervention administration occurring at Day 57 |
Primary Outcome |
Outcome measure 26 - Number of participants in Africa/Stage 2 with unsolicited adverse events (AEs) after the third study intervention administration. Any 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.
|
During 28 days after the third study intervention administration occurring at Day 169 |
Primary Outcome |
Outcome measure 27 - Number of participants in Africa/Stage 2 with SAEs. An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, represents a congenital anomaly/birth defect in the offspring of a study participant or abnormal pregnancy outcomes.
|
From first study intervention administration /Day 1/ up to 28 days after the third study intervention administration /Day 197/ |
Primary Outcome |
Outcome measure 28 - Number of participants in Africa/Stage 2 with AEs/SAEs leading to withdrawal from the study and/or withholding doses of study intervention. Any AEs including SAEs that leads to discontinuation of study intervention and/or the study is considered under this outcome measure.
|
From first study intervention administration /Day 1/ up to 28 days after the third study intervention /Day 197/ |
Primary Outcome |
Outcome measure 29 - Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 8. Panel tests include measures leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
|
At Day 8 - 7 days after the first study intervention administration |
Primary Outcome |
Outcome measure 30 - Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 64. Panel tests include measures leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
|
At Day 64 - 7 days after the second study intervention administration |
Primary Outcome |
Outcome measure 31 - Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 176. Panel tests include measures leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
|
At Day 176 - 7 days after the third study intervention administration |
Primary Outcome |
Outcome measure 32 - Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 29. Panel tests include measures leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
|
At Day 29 - 28 days after the first study intervention administration |
Primary Outcome |
Outcome measure 33 - Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 85. Panel tests include measures leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
|
At Day 85 - 28 days after the second study intervention administration |
Primary Outcome |
Outcome measure 34 - Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 197. Panel tests include measures leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
|
At Day 197 - 28 days after the third study intervention administration |
Secondary Outcome |
Outcome measure 35 - Number of participants with serious adverse events (SAEs). An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, represents a congenital anomaly/birth defect in the offspring of a study participant or abnormal pregnancy outcomes.
|
From 28 days after the third study intervention administration /Day 197/ up to study end /Day 337/ |
Secondary Outcome |
Outcome measure 36 - Number of participants with AEs/SAEs leading to withdrawal from the study
Any AEs including SAEs that leads to discontinuation of the study is considered under this outcome measure.
|
From 28 days after third study intervention administration /Day 197/ up to Day 337 |
Secondary Outcome |
Outcome measure 37 - Anti-serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in participants in Europe/Stage 1, and between group ratios. Anti-S. Typhi Vi antigen (Ag) total IgG, Anti-S. Typhimurium O Ag total IgG, Anti S. Enteritidis O Ag total IgG GMCs and between group ratios are assessed.
|
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 |
Secondary Outcome |
Outcome measure 38 - Anti-serotype specific immunoglobulin G (IgG) within-participant geometric mean ratios (GMRs) in participants in Europe/Stage. Anti-S. Typhi Vi antigen (Ag) total IgG, Anti-S. Typhimurium O Ag total IgG, Anti S. Enteritidis O Ag total IgG within-participant GMRs are assessed.
|
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/ |
Secondary Outcome |
Outcome measure 39 - Number of participants in Europe/Stage 1 achieving, for each antigen (Ag), at least a 4 fold rise in anti serotype specific immunoglobulin G (IgG) antibody concentration. Anti-S. Typhi Vi Ag total IgG, Anti-S. Typhimurium O Ag total IgG, Anti-S. Enteritidis O Ag total IgG antibody concentrations are assessed.
|
At Days 29, 85, and 197 /28 days after each study intervention administration/ compared to Day 1 /first study intervention administration baseline/ |
Secondary Outcome |
Outcome measure 40 - Number of participants in Europe/Stage 1 with Anti-S. typhi Vi Ag IgG antibody concentrations equivalent 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/ |
Secondary Outcome |
Outcome measure 41 - Anti-serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in participants in Africa/Stage 2, and between-group ratio. Anti-S. Typhi Vi Ag total IgG, Anti-S. Typhimurium O Ag total IgG, Anti S. Enteritidis O Ag total IgG GMCs and between-group ratios are assessed.
|
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/ |