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

Hepatitis E Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03365921
Study type Interventional
Source Xiamen Innovax Biotech Co., Ltd
Contact
Status Completed
Phase Phase 4
Start date October 27, 2018
Completion date June 16, 2019
View Details
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