Status:
COMPLETED
A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults
Lead Sponsor:
Peking University
Collaborating Sponsors:
Guangxi Center for Disease Control and Prevention
Liuzhou City Center for disease control and prevention
Conditions:
Hepatitis B
Eligibility:
All Genders
18-25 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- Healthy subjects aged between 16 and 25 as established by medical history and clinical examination
- Written informed consent will be obtained from each subject before the serum screening of HBV markers
- Seronegative for HBsAg, anti-HBs antibody, anti-HBc antibody
- Have never been immunized with HBV vaccine before
Exclusion
- Subject has a medical history of allergic to any ingredient of vaccine
- Family history of seizures or progressive neurological disease
- Autoimmune disease or immunodeficiency
- Women with pregnant
- Bleeding disorder diagnosed by a doctor
- Chronic diseases: hepatitis, tumor, tuberculosis,et.al
- Any prior administration of immunoglobulins or blood products in the last 3 mon before recruitment
- Subjects had a medical history of serious adverse reactions to vaccines
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
353 Patients enrolled
Trial Details
Trial ID
NCT02203357
Start Date
March 1 2014
End Date
December 1 2016
Last Update
October 18 2019
Active Locations (1)
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1
Peking University
Beijing, China, 100191