Clinical Trial: A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety and Immunogenicity Study of the Recombinant Hepatitis E Vaccine(Escherichia Coli) in Healthy Volunteers Aged Over 65 Years
Brief Summary: This phase IV clinical study was designed to evaluate the safety and immunogenicity of the recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 65 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.
Detailed Summary:
Sponsor: Xiamen Innovax Biotech Co., Ltd
Current Primary Outcome: Adverse reactions/events [ Time Frame: up to 10 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Anti-HEV antibody [ Time Frame: 7 months ]
Original Secondary Outcome: Same as current
Information By: Xiamen Innovax Biotech Co., Ltd
Dates:
Date Received: April 11, 2015
Date Started: April 2015
Date Completion:
Last Updated: May 17, 2016
Last Verified: October 2015