NCT07300462

A Post-marketing Observational Study of Oral Cholera Vaccine

A Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Protective Efficacy of Oral Recombinant Subunit B/Bacterial Cholera Vaccine (Enteric-coated Capsules) Against Infectious Diarrhea Caused by Non-Vibrio Cholerae in Healthy People Aged 2 to 14 Years

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6,000 (estimated)
• Sponsor: Shanghai United Cell Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 2 Years – 14 Years
• Healthy volunteers: Accepted

Summary

Chinese survey data indicate that the incidence rate of diarrhea in the general population ranges from 0.17 to 0.70 episodes per person-year, whereas among children under five years of age, the rate is significantly higher, ranging from 2.50 to 3.38 episodes per person-year. Over recent decades, rapid economic development has contributed substantially to the reduction of mortality associated with infectious diseases. However, emerging challenges-such as increasing antimicrobial resistance and heightened population mobility-have complicated efforts in infectious disease prevention and control. In a phase III clinical trial of the recombinant B subunit/bacterial whole-cell cholera vaccine (enteric-coated capsule), a statistically significant difference was observed in the overall incidence of diarrhea between the vaccinated group (12.9%) and the control group (26.7%) (P \< 0.01). Findings from similar vaccine studies conducted in Sweden have demonstrated cross-protection against diarrhea caused by enterotoxigenic Escherichia coli (ETEC) and other intestinal pathogens. Specifically, the vaccine conferred a 50% protection rate against Salmonella enterica infections, 82% against mixed infections involving ETEC and Salmonella, and 71% against mixed infections involving ETEC and other pathogens. Evidence from relevant studies suggests that the recombinant B subunit/bacterial whole-cell cholera vaccine may offer protective benefits against non-cholera infectious diarrhea. Nevertheless, there remains a paucity of real-world effectiveness data, particularly in pediatric populations who bear a disproportionately high burden of diarrheal disease.

Conditions

• Diarrhea

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules)	The participants in the experimental group will be given three oral doses of recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) on D0, D7, and D28 .
BIOLOGICAL	Placebo	The participants in the Control group will be given three oral doses of recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) Placebo on D0, D7, and D28 .

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2025-12-23
• Last updated: 2026-02-09

Locations

5 sites across 1 country: China