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Also known as Low dose of iNTS-TCV, Full dose of iNTS-TCV
iNTS-TCV · 1 trial · 1 indication
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...
iNTS-TCV is an investigational vaccine being developed to protect against invasive nontyphoidal Salmonella disease and typhoid fever. It is in Phase 2 clinical development and is given to infants, with the youngest participants enrolled from 6 weeks of age. It is not yet approved for use.
iNTS-TCV is intended for the prevention of invasive nontyphoidal Salmonella disease and typhoid fever. The ongoing Phase 2 study enrolls healthy infants in The Gambia, starting at 6 weeks of age, to assess whether the vaccine safely produces an immune response against these Salmonella infections.
iNTS-TCV is being developed by GSK plc, which trades under the ticker GSK. The vaccine candidate is part of the company's work in infectious disease, and the current clinical program is sponsored and run by the developer.
iNTS-TCV is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA or any other regulator. One Phase 2 trial is currently recruiting participants, and no trials for this candidate have been completed.
iNTS-TCV is being studied in one active Phase 2 trial, NCT07286370, titled a study to evaluate safety, reactogenicity, and immune response of the GVGH iNTS-TCV vaccine against invasive nontyphoidal Salmonella disease and typhoid fever in infants. The trial is recruiting 537 healthy infants in The Gambia.
Yes. Low dose of iNTS-TCV and full dose of iNTS-TCV refer to the same vaccine candidate, iNTS-TCV, developed by GSK plc. The dose-level names describe the different dose strengths being evaluated within the same clinical program rather than separate products.