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 ]

Measure solicited local adverse reactions within 7 days after each vaccination; Measure solicited systematic adverse reactions within 7 days after each vaccination; Measure unsolicited adverse reactions within 30 days after vaccination; Measure serious adverse events occurred throughout the study


Original Primary Outcome: Same as current

Current Secondary Outcome: Anti-HEV antibody [ Time Frame: 7 months ]

Measure anti-HEV antibody in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine.


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