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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07286370 | A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants | PHASE2 | RECRUITING | 537 | — | — | Apr 1, 2026 | Apr 27, 2028 | Apr 20, 2026 | 1 | The Gambia |
Solicited administration site events included pain, redness, and swelling.
Solicited systemic events included Fever, Irritability/Fussiness, Loss of appetite, Somnolence (sleepiness/drowsiness) and Vomiting. Fever is defined as body temperature more than or equal to (\>=) 37.5 degrees Celsius (°C), measured from axilla.
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
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.
| Arm | Type | Description |
|---|---|---|
| Step 1a- Group 1 iNTS-TCV low dose (6 MOA) | EXPERIMENTAL | Participants 6 MOA receive 3 doses of a low dose of iNTS-TCV at Day 1, Day 85 and Day 337. |
| Step 1a Group 2- Control group (6MOA) | ACTIVE_COMPARATOR | Participants 6 MOA receive TYPHIBEV at Day 1, pneumococcal polysaccharide conjugate vaccine (13 valent) (Prevenar 13) at Day 85, and Nimenrix at Day 337. |
| Step 1b Group 3- iNTS-TCV full dose (6 MOA) | EXPERIMENTAL | Participants 6 MOA receive 3 doses of a full dose of iNTS-TCV at Day 1, Day 85 and Day 337. |
| Step 1b Group 4- iNTS-TCV full dose + Prevenar 13 (6 MOA) | EXPERIMENTAL | Participants 6 MOA receive 2 doses of a full dose of iNTS-TCV at Day 1 and Day 337 and 1 dose of Prevenar 13 at Day 85. |
| Step 1b Group 5- Control Group (6 MOA) | ACTIVE_COMPARATOR | Participants 6 MOA receive TYPHIBEV at Day 1, Prevenar 13 at Day 85, and Nimenrix at Day 337. |
| Step 1c- Group 6- iNTS-TCV low dose (6 WOA) | EXPERIMENTAL | Participants 6 WOA receive 3 doses of a low dose of iNTS-TCV at Day 1, Day 57 and Day 232. |
| Step 1c- Group 7- Control Group (6 WOA) | ACTIVE_COMPARATOR | Participants 6 WOA receive 2 doses of Nimenrix at Day 1 and Day 57, and 1 dose of TYPHIBEV at Day 232 |
| Step 1d- Group 8- iNTS-TCV full dose (6 WOA) | EXPERIMENTAL | Participants 6 WOA receive 3 doses of a full dose of iNTS-TCV at Day 1, Day 57 and Day 232. |
| Step 1d- Group 9- Control Group (6 WOA) | ACTIVE_COMPARATOR | Participants 6 WOA receive 2 doses of Nimenrix at Day 1 and Day 57, and 1 dose of TYPHIBEV at Day 232 |
| Step 2- Group 10- iNTS-TCV low dose (6 WOA) | EXPERIMENTAL | Participants 6 WOA receive 3 doses of a low dose of iNTS-TCV at Day 1, Day 57 and Day 232. |
| Step 2- Group 11- iNTS-TCV low dose+ Saline Group (6 WOA) | EXPERIMENTAL | Participants 6 WOA receive 1 dose of a saline on Day 1 and 2 doses of low dose of iNTS-TCV at Day 57 and Day 232. |
| Step 2- Group 12- iNTS-TCV full dose (6 WOA) | EXPERIMENTAL | Participants 6 WOA receive 3 doses of a full dose of iNTS-TCV at Day 1, Day 57 and Day 232. |
| Step 2- Group 13- iNTS-TCV full dose+ Saline Group (6 WOA) | EXPERIMENTAL | Participants 6 WOA receive 1 dose of saline on Day 1 and 2 doses of full dose of iNTS-TCV at Day 57 and Day 232. |
| Step 2- Group 14 - Control Group (6 WOA) | ACTIVE_COMPARATOR | Participants 6 WOA receive 2 doses of Nimenrix at Day 1 and Day 57, and 1 dose of TYPHIBEV at Day 232 |
| Name | Type | Description |
|---|---|---|
| Low dose of iNTS-TCV | BIOLOGICAL | Low dose of iNTS-TCV vaccine will be administered. |
| Full dose of iNTS-TCV | BIOLOGICAL | Full dose of iNTS-TCV vaccine will be administered. |
| TYPHIBEV | BIOLOGICAL | TYPHIBEV vaccine will be administered. |
| Prevenar 13 | COMBINATION_PRODUCT | Prevenar 13 vaccine will be administered. |
| Nimenrix | COMBINATION_PRODUCT | Nimenrix vaccine will be administered. |
| Saline | DRUG | Saline will be administered. |
Inclusion Criteria: Participants must: 1. Have signed/thumb-printed, voluntary, informed consent provided for them by their parent/Legally Authorized Representative (LAR) prior to performance of any study-specific procedure. 2. Be a male or female infant aged 6 months (±2 weeks) or 6 weeks (+2 wee...