A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(Coadministration With Recombinant Hepatitis B Vaccine)
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.
Biological: HEV vaccine
Biological: HBV vaccine
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Safety and Immunogenicity Study of the Recombinant Hepatitis E Vaccine(Escherichia Coli) Coadministration With Recombinant Hepatitis B Vaccine|
- Adverse reactions/events [ Time Frame: 7 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
- Immunogenicity [ Time Frame: 7 months ]Measure anti-HEV antibody in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine. And measure the HBsAb in serum samples at 7 month to evaluate the immunogenicity of Hepatitis B vaccine.
|Study Start Date:||October 2015|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
|Experimental: HEV vaccine and HBV vaccine Co-administration group||Biological: HEV vaccine Biological: HBV vaccine|
|Active Comparator: HEV vaccine control group||Biological: HEV vaccine|
|Active Comparator: HBV vaccine control group||Biological: HBV vaccine|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02584543
|Contact: Huirong Pan||(+86) firstname.lastname@example.org|
|Beijing Chaoyang District CDC||Recruiting|
|Beijing, Beijing, China|
|Contact: Zheng Zhang (+86)01067773663 email@example.com|
|Principal Investigator:||Zheng Zhang||Beijing Chaoyang District CDC|