WHO ICTRP trial
A Phase 2a study to evaluate the safety, reactogenicity, and immune response of…
PACTR202507692744228 · Pan African Clinical Trials Registry (PACTR) · Not Recruiting
Key facts
| Trial ID | PACTR202507692744228 |
|---|---|
| Public title | A Phase 2a study to evaluate the safety, reactogenicity, and immune response of the GVGH iNTS-TCV vaccine against invasive nontyphoidal Salmonella (iNTS) disease and Typhoid Fever in infants, in Africa |
| Scientific title | A Phase 2a, observer-blind, randomized, controlled, age-de-escalation, single-center interventional study to evaluate the safety, reactogenicity, and immune response of the GVGH iNTS-TCV vaccine against invasive nontyphoidal Salmonella (iNTS) disease and Typhoid Fever, including dose and schedule… |
| Primary sponsor | GlaxoSmithKline Biologicals SA |
| Registry | Pan African Clinical Trials Registry (PACTR) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase-2 |
| Countries | Gambia |
| Conditions | invasive nontyphoidal Salmonella (iNTS) disease and Typhoid Fever;invasive nontyphoidal Salmonella (iNTS) disease and Typhoid Fever |
| Interventions | Step 1a Group 1 iNTS TCV low dose at 6 MOA ;Step 1a Control group 2 controls used in this group are TYPHIBEV Prevenar 13 and Nimenrix;Step 1b Group 3 iNTS TCV full dose at 6 MOA;Step 1b Group 4 iNTS TCV full dose including Prevenar 13 at 6… |
| Registration date | Jul 31, 2025 |
| Target size | 537 |
| Registry page | pactr.samrc.ac.za |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: