Clinical Trial: A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(Coadministration With Recombinant Hepatitis B Vaccine)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Safety and Immunogenicity Study of the Recombinant Hepatitis E Vaccine(Escherichia Coli) Coadministration With Recombinant Hepatitis B Vaccine
Brief Summary:
This is a open label, randomized phase VI study, to assess the safety and immunogenicity of co-administration of Hepatitis E vaccine with Hepatitis B vaccine. The concomitant group (n =300) received Hepatitis B vaccine concomitantly with Hepatitis E vaccine at day 1 and months 1 and 6; The nonconcomitant group (n =150) received Hepatitis E vaccine at at day 1 and months 1 and 6. Another nonconcomitant group (n=150) received Hepatitis B vaccine at at day 1 and months 1 and 6.
Anti-HEV IgG and HBsAb were determined. Injection-site and systemic adverse events (AEs) were monitored for 30 days after any vaccination; serious AEs were monitored throughout the study.
Detailed Summary:
Sponsor: Xiamen Innovax Biotech Co., Ltd
Current Primary Outcome: Adverse reactions/events [ Time Frame: 7 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Immunogenicity [ Time Frame: 7 months ]
Original Secondary Outcome: Same as current
Information By: Xiamen Innovax Biotech Co., Ltd
Dates:
Date Received: October 21, 2015
Date Started: October 2015
Date Completion: October 31, 2017
Last Updated: May 14, 2017
Last Verified: May 2017