NCT03365921

A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Lot Consistency Trial)

An Randomized, Double-blinded Trial of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin® to Evaluate Lot-to-lot Consistency

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Xiamen Innovax Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate lot-lot consistency of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin®.

Detailed description

This study is a mono-center, randomization, double-blind clinical trial in healthy subjects between 18 to 50. Under the premise of full informed consent, 360 subjects that meet the requirement of clinical trial in the age of 18-50 will be divided into 3 groups and injected 3 consecutive batches of Hecolin® separately. The main outcome measures are the immunogenicity evaluation and safety surveillance after inoculation according to prescribed immunization procedure.

Conditions

• Hepatitis E

Interventions

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

Timeline

• Start date: 2018-10-27
• Primary completion: 2019-06-16
• Completion: 2019-06-16
• First posted: 2017-12-07
• Last updated: 2020-05-07

Locations

1 site across 1 country: China