At a glance
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A Phase 3, Randomized, Double-blind, Placebo (Hepatitis B Vaccine) Controlled Clinical Trial of Recombinant (E. Coli) Hepatitis E Vaccine
In Brief
A Phase 3 clinical trial evaluating hepatitis E vaccine and Hepatitis B vaccine for Hepatitis E. Completed, enrolled 112,604 participants across 1 site.
Detailed Summary
The primary purpose of this study is to determine whether the preventive hepatitis E are effective in the prevention of hepatitis E occurring at least 30 days after the administration of the third dose of vaccine. The secondary purpose of this study is to to evaluate the safety and immunogenicity and immunopersistence of the study vaccine. The initial study is planed to be ended on month 19 and the results were analysed and used for registration purpose. The extended study will be continued to assess the long-term efficacy, immunogenicity and safety.
Study Details
Timeline
Interventions
Intramuscularly given at 0, 1, 6m for three doses.
Intramuscularly given at 0, 1, 6m for three doses.