NCT06838195

Clinical Trial of the S. Flexneri-S. Sonnei Bivalent Conjugate Vaccine

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Protective Efficacy, Immunogenicity, and Safety of the S. Flexneri-S. Sonnei Bivalent Conjugate Vaccine in Infants and Children Aged 6 Months to 5 Years in Bangladesh

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,000 (estimated)
• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate the protective efficacy of S. Flexneri-S. Sonnei bivalent conjugate vaccine against diarrhea caused by Shigella infection in infants and children aged 6 months to 5 years. Researchers will observe the incidence of diarrhea of any severity due to Shigella flexneri and Shigella sonnei infection 30 days after full immunization. The subjects will receive 2 doses of vaccination.

Conditions

• Dysentery
• Dysentery, Shigella

Interventions

Type	Name	Description
BIOLOGICAL	S. Flexneri-S. Sonnei bivalent conjugate vaccine	Subjects receive two doses of the vaccine on the day of randomisation (day 0) and day 30.
BIOLOGICAL	Placebo	Subjects receive two doses of the placebo on the day of randomisation (day 0) and day 30.

Timeline

• Start date: 2025-05-12
• Primary completion: 2028-07-02
• Completion: 2028-07-30
• First posted: 2025-02-20
• Last updated: 2026-04-01

Locations

1 site across 1 country: Bangladesh