Seroprevalence of Hepatitis B and Immune Response to Hepatitis B Vaccination in Chinese College Students

NCT ID: NCT01861613

Last Updated: 2013-05-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2040 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Brief Summary

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At present, children less than 15 y of age have been regarded as a key group for hepatitis B immunization in China. However, there is not yet special immunization strategy for population above 15 y of age. In this study, we investigated the seroprevalence of hepatitis B and immune response to HB vaccine among Chinese college students to uncover the need on universal mass vaccination or booster immunization only for students with HBV vaccination history against hepatitis B in Chinese college students to inform decision making.

Detailed Description

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Conditions

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Hepatitis B Immune Response Seroprevalence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HBV vaccine

HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)

Group Type EXPERIMENTAL

HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)

Intervention Type BIOLOGICAL

Interventions

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HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male and female freshmen in one college in Liuzhou city of Guangxi Zhuang Autonomous Region

Exclusion Criteria

* acute illness
* immunocompromised conditions
* renal insufficiency
* pregnancy
* allergic history to HB vaccine or yeast
* positive for any of HBsAg, anti-HBs or anti-HBc
Minimum Eligible Age

16 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangxi Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role collaborator

Hui Zhuang

OTHER

Sponsor Role lead

Responsible Party

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Hui Zhuang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Guangxi Centers for Disease Control and Prevention

Nanning, Guangxi, China

Site Status

Countries

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China

Other Identifiers

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PRO-HBV-001

Identifier Type: -

Identifier Source: org_study_id

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