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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

353 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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20μg, 0-1-6

117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.

Group Type ACTIVE_COMPARATOR

Hepatitis B vaccine

Intervention Type BIOLOGICAL

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

60μg, 0-1

112 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.

Group Type EXPERIMENTAL

Hepatitis B vaccine

Intervention Type BIOLOGICAL

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

60μg, 0-2

125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.

Group Type EXPERIMENTAL

Hepatitis B vaccine

Intervention Type BIOLOGICAL

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

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No