Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05480800 | A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever | PHASE1 | COMPLETED | 155 | — | — | Sep 13, 2022 | Jan 7, 2025 | Nov 28, 2025 | 2 | Belgium, Malawi |
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Stage 1: Invasive nontyphoidal Salmonella (iNTS)-Typhoid conjugate vaccine (TCV) low dose group | EXPERIMENTAL | 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. |
| Stage 1: iNTS-Generalized modules for membrane antigens (GMMA) + TCV low dose group | ACTIVE_COMPARATOR | 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. |
| Stage 1: iNTS-TCV full dose group | EXPERIMENTAL | 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. |
| Stage 1: iNTS-GMMA + TCV full dose group | ACTIVE_COMPARATOR | 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. |
| Stage 1: Placebo group | PLACEBO_COMPARATOR | 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. |
| Stage 2: iNTS-TCV full dose group | EXPERIMENTAL | 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. |
| Stage 2: iNTS-GMMA + TCV full dose group | ACTIVE_COMPARATOR | 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. |
| Stage 2: Control group | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) low dose | BIOLOGICAL | 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). |
| Invasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) low dose | BIOLOGICAL | 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). |
| Typhoid conjugate vaccine (TCV) low dose | BIOLOGICAL | 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). |
| Invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) full dose | BIOLOGICAL | 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). |
| Invasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) full dose | BIOLOGICAL | 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). |
| Typhoid conjugate vaccine (TCV) full dose | BIOLOGICAL | 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). |
| GSK's Meningococcal A, C, Y and W-135 conjugate vaccine | BIOLOGICAL | 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). |
| GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine | COMBINATION_PRODUCT | 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). |
| Sanofi Pasteur's Typhoid Vi polysaccharide vaccine | COMBINATION_PRODUCT | 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). |
| Placebo | DRUG | 3 doses of Placebo administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the Placebo Group in Stage 1 (Europe). |
| Saline | OTHER | 3 doses of saline solution administered intramuscularly at Day 1, Day 57, and Day 169 to the participants. |
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 ...