NCT03168412

A Study on the Recombinant Hepatitis E Vaccine (Escherichia Coli) (Accelerated Vaccination Schedule)

A Study on Immunogenicity of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin® Using Accelerated Vaccination Schedule in Adults (Aged Over 18 Years)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Xiamen Innovax Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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 healthy adults (over 18 years) with accelerated vaccination schedule. The study volunteers will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-7-21 days schedule or 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, 7, 21 days.
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: 2017-05-25
• Primary completion: 2018-07-15
• Completion: 2018-11-28
• First posted: 2017-05-30
• Last updated: 2019-02-21

Locations

1 site across 1 country: China