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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05073003 | A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants | PHASE1 | COMPLETED | 551 | — | — | Oct 6, 2021 | Jun 24, 2025 | Dec 4, 2025 | 2 | Belgium, Kenya |
Anti-serotype specific Shigella LPS/OAg serum IgG GMCs are measured by GSK Vaccines Institute for Global Health (GVGH) enzyme-linked immunosorbent assay (ELISA) and expressed in ELISA units per milliliter (EU/mL) of serum.
The solicited administration site events are pain, redness, and swelling.
The solicited systemic event is fever. Fever is defined as temperature equal to or above (≥) 38.0°C. The preferred location for measuring temperature is the axilla for all participants.
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 adverse event.
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.
Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, blood urea, sodium, potassium, aspartate aminotransferase (AST) and alanine aminotransferase (ALT).
Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, blood urea, sodium, potassium, aspartate aminotransferase (AST) and alanine aminotransferase (ALT).
The solicited administration site events are pain, redness, and swelling.
The solicited systemic event is fever. Fever is defined as temperature ≥ 38.0°C. The preferred location for measuring temperature is the axilla for all participants.
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 adverse event.
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.
Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, blood urea, sodium, potassium, AST, and ALT.
Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, blood urea, sodium, potassium, AST, and ALT.
The solicited administration site events are pain, redness, and swelling.
The solicited systemic event is fever. Fever is defined as temperature ≥ 38.0°C. The preferred location for measuring temperature is the axilla for all participants.
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 adverse event.
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 or any other situation based on appropriate medical or scientific judgement.
Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, blood urea, sodium, potassium, AST, and ALT.
Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, blood urea, sodium, potassium, AST, and ALT.
The solicited administration site events are pain, redness and swelling.
The solicited systemic event is fever. Fever is defined as temperature ≥ 38.0°C. The preferred location for measuring temperature is the axilla for all participants.
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 adverse event.
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 or any other situation based on appropriate medical or scientific judgement.
Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, blood urea, sodium, potassium, AST, and ALT.
Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, blood urea, sodium, potassium, AST, and ALT.
Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, blood urea, sodium, potassium, AST, and ALT.
| Arm | Type | Description |
|---|---|---|
| ST1_Adults_Placebo_GR1 Group | PLACEBO_COMPARATOR | Adults 18 to 50 years of age in Stage 1 (Europe) randomized to receive two doses of altSonflex Placebo, one each at Day 1 and Day 85. |
| ST1_Adults_Dose C_GR1 Group | EXPERIMENTAL | Adults 18 to 50 years of age in Stage 1 (Europe) randomized to receive two doses of altSonflex1-2-3 Dose C vaccine, one each at Day 1 and Day 85. |
| ST1_Adults_Placebo_GR2 Group | PLACEBO_COMPARATOR | Adults 18 to 50 years of age in Stage 1 (Europe) randomized to receive two doses of altSonflex Placebo, one each at Day 1 and Day 169. |
| ST1_Adults_Dose C_GR2 Group | EXPERIMENTAL | Adults 18 to 50 years of age in Stage 1 (Europe) randomized to receive two doses of altSonflex1-2-3 Dose C vaccine, one each at Day 1 and Day 169. |
| ST2_Adults_Control C Group | ACTIVE_COMPARATOR | Adults 18 to 50 years of age in Stage 2 (Africa) randomized to receive one dose of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine at Day 1 and one dose of GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine at Day 85. |
| ST2_Adults_Dose C Group | EXPERIMENTAL | Adults 18 to 50 years of age in Stage 2 (Africa) randomized to receive two doses of altSonflex1-2-3 Dose C vaccine, one each at Day 1 and Day 85. |
| ST2_Children_Control B Group | ACTIVE_COMPARATOR | Children 24 to 59 months of age in Stage 2 (Africa) randomized to receive one dose of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine at Day 1 and one dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine at Day 85. This group is a control group for children receiving altSonflex1-2-3 Dose B vaccine. |
| ST2_Children_Dose B Group | EXPERIMENTAL | Children 24 to 59 months of age in Stage 2 (Africa) randomized to receive two doses of altSonflex1-2-3 Dose B vaccine, one each at Day 1 and Day 85. |
| ST2_Children_Control C Group | ACTIVE_COMPARATOR | Children 24 to 59 months of age in Stage 2 (Africa) randomized to receive one dose of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine at Day 1 and one dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine at Day 85. This group is a control group for children receiving altSonflex1-2-3 Dose C vaccine. |
| ST2_Children_Dose C Group | EXPERIMENTAL | Children 24 to 59 months of age in Stage 2 (Africa) randomized to receive two doses of altSonflex1-2-3 Dose C vaccine, one each at Day 1 and Day 85. |
| ST2_Infants_Control A_Safety Group | ACTIVE_COMPARATOR | Infants 9 months of age in Stage 2 (Africa), part of the safety cohort, randomized to receive two doses of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine, one each at Day 1 and Day 85, and one dose of GSK's Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccine at Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 29 and Day 281, as concomitant vaccination. This group is a control group for infants receiving altSonflex1-2-3 Dose A vaccine. |
| ST2_Infants_Dose A_Safety Group | EXPERIMENTAL | Infants 9 months of age in Stage 2 (Africa), part of the safety cohort, randomized to receive three doses of altSonflex1-2-3 Dose A, one each at Day 1, Day 85 and Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 29 and Day 281, as concomitant vaccination. |
| ST2_Infants_Control B_Safety Group | ACTIVE_COMPARATOR | Infants 9 months of age in Stage 2 (Africa), part of the safety cohort, randomized to receive two doses of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine, one each at Day 1 and Day 85, and one dose of GSK's Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccine at Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 29 and Day 281, as concomitant vaccination. This group is a control group for infants receiving altSonflex1-2-3 Dose B vaccine. |
| ST2_Infants_Dose B_Safety Group | EXPERIMENTAL | Infants 9 months of age in Stage 2 (Africa), part of the safety cohort, randomized to receive three doses of altSonflex1-2-3 Dose B vaccine, one each at Day 1, Day 85 and Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 29 and Day 281, as concomitant vaccination. |
| ST2_Infants_Control C_Safety Group | ACTIVE_COMPARATOR | Infants 9 months of age in Stage 2 (Africa), part of the safety cohort, randomized to receive two doses of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine, one each at Day 1 and Day 85, and one dose of GSK's Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccine at Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 29 and Day 281, as concomitant vaccination. This group is a control group for infants receiving altSonflex1-2-3 Dose C vaccine. |
| ST2_Infants_Dose C_Safety Group | EXPERIMENTAL | Infants 9 months of age in Stage 2 (Africa), part of the safety cohort, randomized to receive three doses of altSonflex1-2-3 Dose C vaccine, one each at Day 1, Day 85 and Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 29 and Day 281, as concomitant vaccination. |
| ST2_Infants_Control_Dose find Group | ACTIVE_COMPARATOR | Infants 9 months of age in Stage 2 (Africa), part of the dose-finding cohort, randomized to receive two doses of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine, one each at Day 1 and Day 85, and one dose of GSK's Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccine at Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 1 and Day 253, as concomitant vaccination. This group is a control group for infants in dose-finding groups receiving either altSonflex1-2-3 Dose A, Dose B or Dose C vaccine. |
| ST2_Infants_Dose A_Dose find Group | EXPERIMENTAL | Infants 9 months of age in Stage 2 (Africa), part of the dose-finding cohort, randomized to receive three doses of altSonflex1-2-3 Dose A vaccine, one each at Day 1, Day 85 and Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 1 and Day 253, as concomitant vaccination. |
| ST2_Infants_Dose B_Dose find Group | EXPERIMENTAL | Infants 9 months of age in Stage 2 (Africa), part of the dose-finding cohort, randomized to receive three doses of altSonflex1-2-3 Dose B vaccine, one each at Day 1, Day 85 and Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 1 and Day 253, as concomitant vaccination. |
| ST2_Infants_Dose C_Dose find Group | EXPERIMENTAL | Infants 9 months of age in Stage 2 (Africa), part of the dose-finding cohort, randomized to receive three doses of altSonflex1-2-3 Dose C vaccine, one each at Day 1, Day 85 and Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 1 and Day 253, as concomitant vaccination. |
| Name | Type | Description |
|---|---|---|
| altSonflex Placebo | DRUG | 2 doses of altSonflex Placebo, administered intramuscularly, in the non-dominant arm, either at Day 1 and Day 85 or at Day 1 and Day 169 (depending on the vaccination schedule) to adults in the ST1\_Adults\_Placebo\_GR1 and ST1\_Adults\_Placebo\_GR2 groups in Stage 1 (Europe). |
| altSonflex1-2-3 Dose C | BIOLOGICAL | 2 doses of altSonflex1-2-3 Dose C administered intramuscularly, in the non-dominant arm, at Day 1 and Day 85 to adults in the ST1\_Adults\_Dose C\_GR1 and ST2\_Adults\_Dose C groups in Stage 1 and 2 (Europe and Africa) and children in the ST2\_Children\_Dose C group in Stage 2 (Africa), and at Day 1 and Day 169 to adults in the ST1\_Adults\_Dose C\_GR2 group in Stage 1 (Europe); 3 doses of altSonflex1-2-3 Dose C administered intramuscularly, in the non-dominant arm, at Day 1, Day 85 and Day 253 to infants in the ST2\_Infants\_Dose C\_Safety and ST2\_Infants\_Dose C\_Dose find groups in Stage 2 (Africa). |
| altSonflex1-2-3 Dose B | BIOLOGICAL | 2 doses of altSonflex1-2-3 Dose B administered intramuscularly, in the non-dominant arm, at Day 1 and Day 85 to children in the ST2\_Children\_Dose B group in Stage 2 (Africa); 3 doses of altSonflex1-2-3 Dose B administered intramuscularly, in the non-dominant arm, at Day 1, Day 85 and Day 253 to infants in the ST2\_Infants\_Dose B\_Safety and ST2\_Infants\_Dose B\_Dose find groups in Stage 2 (Africa). |
| altSonflex1-2-3 Dose A | BIOLOGICAL | 3 doses of altSonflex1-2-3 Dose A administered intramuscularly, in the non-dominant arm, at Day 1, Day 85 and Day 253 to infants in the ST2\_Infants\_Dose A\_Safety and ST2\_Infants\_Dose A\_Dose find groups 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, in the non-dominant arm, at Day 1 to adults in the ST2\_Adults\_Control C group and children in the ST2\_Children\_Control B and ST2\_Children\_Control C groups in Stage 2 (Africa); 2 doses of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine administered intramuscularly, in the non-dominant arm, at Day 1 and Day 85 to infants in the ST2\_Infants\_Control A\_Safety, ST2\_Infants\_Control B\_Safety, ST2\_Infants\_Control C\_Safety and ST2\_Infants\_Control\_Dose find groups 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, in the non-dominant arm, at Day 85 to adults in the ST2\_Adults\_Control C group in Stage 2 (Africa). |
| GSK's Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccine | COMBINATION_PRODUCT | 1 dose of GSK's Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccine administered intramuscularly, in the non-dominant arm, at Day 253 to infants in the ST2\_Infants\_Control A\_Safety, ST2\_Infants\_Control B\_Safety, ST2\_Infants\_Control C\_Safety and ST2\_Infants\_Control\_Dose find groups 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, in the non-dominant arm, at Day 85 to children in the ST2\_Children\_Control B and ST2\_Children\_Control C groups in Stage 2 (Africa). |
| Serum Institute of India's Measles and rubella vaccine | BIOLOGICAL | 2 doses of Serum Institute of India's Measles and rubella vaccine administered subcutaneously, in the non-dominant arm, at Day 29 and Day 281 to infants in the safety groups, and at Day 1 and Day 253 to infants in the dose-finding groups, in Stage 2 (Africa). |
Inclusion Criteria: All participants: * Participants and/or participants' parent(s)/legally acceptable representative(s) LAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). * W...