Safety and Immunogenicity Study of IP-QSV Vaccine in Healthy Adults/Adolescents, Children and Infants

Summary

The goal of this phase 1/2a, randomized, observer-blind, age-descending, dose-finding trial is to evaluate the safety and immunogenicity of a quadrivalent synthetic oligosaccharide-based Shigella vaccine (adjuvanted IP-QSV) in adults, children, and infants in Mali. This first-in-human study is intended to obtain initial data on the safety of the adjuvanted IP-QSV vaccine and its effect on immune responses in a Shigella-endemic region.

Timeline

Start

2026-07

Primary completion

2027-08

Completion

2028-11

Drugs

Indications