NCT02964910

A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Chronic Hepatitis B Patients )

An Open, Pared Trial of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin® in the Chronic Hepatitis B Patients on the Clinical Stability .( Aged 30 Years or Over)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 475 (actual)
• Sponsor: Xiamen Innovax Biotech Co., Ltd · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

Summary

This phase IV clinical study was designed to evaluate the immunogenicity and safety of Hecolin® in the chronic Hepatitis B patients on the clinical stability.

Detailed description

This phase IV clinical study was designed to evaluate the immunogenicity and safety of the recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in the chronic Hepatitis B patients on the clinical stability and aged over 30 years of age at enrollment. The study volunteers will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-1-6 month schedule.

Conditions

• Hepatitis E

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Hepatitis E Vaccine (Escherichia Coli)	Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-08-01
• Completion: 2017-12-01
• First posted: 2016-11-16
• Last updated: 2019-07-25
• Results posted: 2019-07-25

Locations

1 site across 1 country: China