NCT02203357

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	Hepatitis B vaccine	Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-06-01
• Completion: 2016-12-01
• First posted: 2014-07-29
• Last updated: 2019-10-18
• Results posted: 2019-10-03

Locations

1 site across 1 country: China