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

Primary Purpose

Hepatitis B, Immune Response, Seroprevalence

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)
Sponsored by
Hui Zhuang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B

Eligibility Criteria

16 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria for vaccination study:

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

Sites / Locations

  • Guangxi Centers for Disease Control and Prevention

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HBV vaccine

Arm Description

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

Outcomes

Primary Outcome Measures

Anti-HBs immune response in participants negative for HB sAg, anti-HBs and anti-HBc

Secondary Outcome Measures

Seroprevalence for HBsAg, anti-HBs and anti-HBc in Chinese college students
Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc
Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc
Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc

Full Information

First Posted
May 19, 2013
Last Updated
May 23, 2013
Sponsor
Hui Zhuang
Collaborators
Guangxi Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01861613
Brief Title
Seroprevalence of Hepatitis B and Immune Response to Hepatitis B Vaccination in Chinese College Students
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hui Zhuang
Collaborators
Guangxi Center for Disease Control and Prevention

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Immune Response, Seroprevalence

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2040 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HBV vaccine
Arm Type
Experimental
Arm Description
HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)
Intervention Type
Biological
Intervention Name(s)
HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)
Primary Outcome Measure Information:
Title
Anti-HBs immune response in participants negative for HB sAg, anti-HBs and anti-HBc
Time Frame
Anti-HBs was assayed at Month 7
Secondary Outcome Measure Information:
Title
Seroprevalence for HBsAg, anti-HBs and anti-HBc in Chinese college students
Time Frame
seroprevalence at baseline
Title
Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc
Time Frame
Anti-HBs immune response at Month 1
Title
Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc
Time Frame
Anti-HBs immune response at Month 6
Title
Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc
Time Frame
Anti-HBs immune response at Month 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female freshmen in one college in Liuzhou city of Guangxi Zhuang Autonomous Region Exclusion Criteria for vaccination study: acute illness immunocompromised conditions renal insufficiency pregnancy allergic history to HB vaccine or yeast positive for any of HBsAg, anti-HBs or anti-HBc
Facility Information:
Facility Name
Guangxi Centers for Disease Control and Prevention
City
Nanning
State/Province
Guangxi
Country
China

12. IPD Sharing Statement

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

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