Status: Not yet recruiting
Safety and Immunogenicity Study of IP-QSV Vaccine in Healthy Adults/Adolescents, Children and Infants
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.
Participants needed: 370
Trial details
Phase: Phase 1, Phase 2Age: 6-45Biological sex: AllType: InterventionalSponsor: International Vaccine InstituteUpdated: Jun 24, 2026
Eligibility criteria
Individuals aged 18-45 years in Group A, 2-5 years in Groups B and C, 6-8 months... [+3]
Known history or allergy to investigational vaccine components or other medicati... [+22]