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

StatusCompleted
PhasePhase 2
Started2024-01-15
View on ClinicalTrials.gov ↗
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.

Amendment history 3 changes detected by DataLookout

2026-09-03
Trial completed
2026-09-03
Enrollment reduced: 215 → 183 participants
2026-09-03
Primary completion confirmed: August 2026 (last estimated September 2026)
Trial Details
NCT Number NCT06213506
Lead Sponsor GlaxoSmithKline
Conditions Salmonella Infections
Enrollment 183 participants
Start Date 2024-01-15
Primary Completion 2026-08-06 (estimated)
Study Completion 2026-08-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-02