Dose of Hepatitis B Vaccines in Non/Low-response Populations
NCT ID: NCT01564134
Last Updated: 2013-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
537 participants
INTERVENTIONAL
2011-08-31
2012-06-30
Brief Summary
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Detailed Description
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The clinical program approved by the ethics committee will be performed by the researchers independently. Inspectors designated by the sponsor will take meticulous on-site audits to ensure the safety specifications during the whole process of research.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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HepB 5ug
receive the vaccine with 5ug HBsAg
hepatitis B vaccine
hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
HepB 10ug
receive the vaccine with 10ug HBsAg
hepatitis B vaccine
hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
HepB 20ug
receive the vaccine with 20ug HBsAg
hepatitis B vaccine
hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
HepB 60ug
receive the vaccine with 60ug HBsAg
hepatitis B vaccine
hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
Interventions
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hepatitis B vaccine
hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* male or non-pregnant female volunteers
* provide written informed consents before joining the trial
* clinically healthy as determined by: medical history inquiring and physical examination
* negative for HBsAg,HBsAb,HBcAb,HBeAg,HBeAb within the past 1 year
Exclusion Criteria
* receipt of immunoglobulin within the past 1 month
* allergic to any ingredient of vaccine
* history of serious side effects, such as allergies, hives, breathing difficulties, angioedema or abdominal pain
* severe acute and chronic diseases
* autoimmune disease or immune deficiency
* axillary temperature \> 37.0 ℃ over the time of vaccination
1 Year
65 Years
ALL
Yes
Sponsors
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Beijing Municipal Science & Technology Commission
OTHER
Wu Jiang
OTHER_GOV
Responsible Party
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Wu Jiang
Department of Immunization & Prevention
Principal Investigators
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jiang wu, Bachelor
Role: PRINCIPAL_INVESTIGATOR
Beijing Centers for Disease Control and Prevention
Locations
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Xicheng Centers For Disease Prevention & Control
Xicheng District, Beijing Municipality, China
Chifeng Centers For Disease Prevention & Control
Chifeng, Inner Mongolia, China
Countries
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Other Identifiers
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BJCDCWJ201102
Identifier Type: -
Identifier Source: org_study_id
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