NCT06523231

Study to Expand Safety and Immunogenicity Data With Shigella Bioconjugate Vaccine (Shigella4V2) in 9-month-old Infants.

Safety and Immunogenicity of a Second Generation Shigella Bioconjugate Vaccine: a Phase II Randomized, Controlled, and Blinded Study in 9-month-old Infants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: LimmaTech Biologics AG · Industry
• Sex: All
• Age: 8 Months – 10 Months
• Healthy volunteers: Accepted

Summary

In this study, the second-generation tetravalent bioconjugate candidate vaccine Shigella4V2 will be tested to confirm data on its safety and immunogenicity in infants and to identify the best dose of Shigella4V2 in 9-month-old infants.

Detailed description

Shigella4V2 is the second generation of a tetravalent bioconjugate vaccine including O-antigen-polysaccharides of the most predominant Shigella serotypes. During the study, infants will be randomized to receive 1 of 2 different vaccine doses, or a control vaccine. Participants will receive a 2-dose schedule. Each vaccine dose is formulated with Aluminium adjuvant.

Conditions

• Shigellosis

Interventions

Type	Name	Description
BIOLOGICAL	Shigella4V2	Adjuvanted Shigella4V2 administrated at 2 different doses: low and high.
BIOLOGICAL	MenACWY	Control vaccine

Timeline

• Start date: 2025-04-07
• Primary completion: 2025-08-27
• Completion: 2026-01-22
• First posted: 2024-07-26
• Last updated: 2026-02-09

Locations

1 site across 1 country: Kenya