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

NCT06838195 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8000

Last updated 2026-04-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Lin Du · Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-12
Primary Completion
2028-07-02
Completion
2028-07-30

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06838195 on ClinicalTrials.gov