drugset
drugset / Trial / NCT06213506

A Study on the Safety, Reactogenicity, and Immune Response to the GVGH iNTS-GMMA Vaccine Against Invasive Nontyphoidal Salmonella in Adults, Children, and Infants

NCT06213506 ↗

Phase 2 Completed 180 enrolled GlaxoSmithKline
RandomizedSequentialQuadruple-blindPrevention

Summary

The purpose of this study is to evaluate the safety, reactogenicity, and immune response of the GlaxoSmithKline (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-generalized modules for membrane antigens (iNTS-GMMA) candidate vaccine against S. Typhimurium and S. Enteritidis with an age de-escalation and dose escalation approach in African population, starting with adults (18-50 years of age), then in children (24-59 months of age) and finally in infants (9 months and 6 weeks of age). Infants are the target for primary vaccination from 6 weeks of age.

Timeline

Start
2024-01-15
Primary completion
2026-08-06
Completion
2026-08-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator MenACWY Vaccine — Intramuscular
Subject iNTS-GMMA Vaccine — Intramuscular
Background DTPa-HBV-IPV+Hib Vaccine — Intramuscular
Background Measles and Rubella vaccine Vaccine — —
Background Yellow Fever Vaccine Vaccine — —

Indications

salmonellosis