drugset / Trial / NCT02203357

A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults

NCT02203357

RandomizedParallel-groupOpen-labelPrevention

Summary

The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young adults, and the comparative immunogenicity among the three groups will be measured at 1 mon post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore, the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.

Timeline

Start
2014-03
Primary completion
2016-06
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Hepatitis B vaccine Vaccine 20 ug
Subject Hepatitis B vaccine Vaccine 60 ug