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Clinical Trial of the S. Flexneri-S. Sonnei Bivalent Conjugate Vaccine
Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
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.
Official title: 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
Key Details
Gender
All
Age Range
6 Months - 5 Years
Study Type
INTERVENTIONAL
Enrollment
8000
Start Date
2025-05-12
Completion Date
2028-07-30
Last Updated
2026-04-01
Healthy Volunteers
Yes
Conditions
Interventions
S. Flexneri-S. Sonnei bivalent conjugate vaccine
Subjects receive two doses of the vaccine on the day of randomisation (day 0) and day 30.
Placebo
Subjects receive two doses of the placebo on the day of randomisation (day 0) and day 30.
Locations (1)
Icddr,B
Dhaka, Bangladesh