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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01861613
Other study ID # PRO-HBV-001
Secondary ID
Status Completed
Phase Phase 4
First received May 19, 2013
Last updated May 23, 2013
Start date September 2009

Study information

Verified date May 2013
Source Peking University
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 2040
Est. completion date
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 16 Years to 30 Years
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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


Locations

Country Name City State
China Guangxi Centers for Disease Control and Prevention Nanning Guangxi

Sponsors (2)

Lead Sponsor Collaborator
Hui Zhuang Guangxi Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anti-HBs immune response in participants negative for HB sAg, anti-HBs and anti-HBc Anti-HBs was assayed at Month 7 No
Secondary Seroprevalence for HBsAg, anti-HBs and anti-HBc in Chinese college students seroprevalence at baseline No
Secondary Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc Anti-HBs immune response at Month 1 No
Secondary Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc Anti-HBs immune response at Month 6 No
Secondary Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc Anti-HBs immune response at Month 20 No
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