Clinical Trial: Phase Ⅳ Clinical Trial of Recombinant Hepatitis E Vaccine（Hecolin®）

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Evaluation of Safety and Immunogenicity of Recombinant (E. Coli) Hepatitis E Vaccine（Hecolin®） in Seniors Aged Over 65 Years

Brief Summary: The purpose of this study is to determine the safety and immunogenicity of the recombinant hepatitis E vaccine in people older than 65 years, and evaluate the efficacy of hepatitis E vaccine in this population.

Detailed Summary:
Sponsor: Jun Zhang

Current Primary Outcome: Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: From month 0-7 ]

Any adverse events reported within one month post each vaccination would be recorded, any serious adverse events reported throughout the study would be recorded.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • anti-HEV IgG seropositive rate [ Time Frame: at month 7 ]
  • GMT of anti-HEV IgG [ Time Frame: 7 month after first vaccination ]
    Serum sample would be collected at month 7, and geometric mean titer of anti-HEV IgG would be tested


Original Secondary Outcome: Same as current

Information By: Xiamen University

Dates:
Date Received: July 9, 2014
Date Started: June 2014
Date Completion: February 2015
Last Updated: July 10, 2014
Last Verified: July 2014