Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06838195
PHASE3

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

Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Icddr,B

Dhaka, Bangladesh