drugset / Trial / NCT02603055

A Clinical Trial to Evaluate a Recombinant Hepatitis E Vaccine in Healthy Adults

NCT02603055

RandomizedParallel-groupDouble-blindPrevention

Summary

Hepatitis E is characteristic by sporadic and local epidemic around the world, and mainly infects adults aged 15 to 40 years old, resulting in the infection rate ranged from 1% to 15%. The investigational hepatitis E vaccine is a recombinant aluminium-adjuvant hepatitis E vaccine. This is a single center, randomized, blinding, parallel-controlled phase Ib clinical trial. This study will determine the safety and immunogenicity of the investigational recombinant hepatitis E vaccine in healthy adults between 16 and 65 years.

Timeline

Start
2015-07
Primary completion
2016-04
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Hecolin® Vaccine 30 ug
Comparator Recombinant Hepatitis E vaccine Vaccine 30 ug