drugset / Trial / NCT02203357
A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults
Phase 4
Completed
353 enrolled
Peking University
Guangxi Center for Disease Control and Prevention · collabLiuzhou City Center for disease control and prevention · collabShenzhen Kangtai Biological Products Co., LTD · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hepatitis B vaccine | Vaccine | 20 ug | — |
| Subject | Hepatitis B vaccine | Vaccine | 60 ug | — |