NCT02584543

A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(Coadministration With Recombinant Hepatitis B Vaccine)

Safety and Immunogenicity Study of the Recombinant Hepatitis E Vaccine(Escherichia Coli) Coadministration With Recombinant Hepatitis B Vaccine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 602 (actual)
• Sponsor: Xiamen Innovax Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis E
• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	HEV vaccine
BIOLOGICAL	HBV vaccine

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-08-25
• Completion: 2016-08-25
• First posted: 2015-10-22
• Last updated: 2017-12-04

Locations

1 site across 1 country: China