NCT01861613

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,040

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2013

Completed
Last Updated

May 24, 2013

Status Verified

May 1, 2013

Enrollment Period

2.2 years

First QC Date

May 19, 2013

Last Update Submit

May 23, 2013

Conditions

Hepatitis BImmune ResponseSeroprevalence

Outcome Measures

Primary Outcomes (1)

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

    Anti-HBs was assayed at Month 7

Secondary Outcomes (4)

  • Seroprevalence for HBsAg, anti-HBs and anti-HBc in Chinese college students

    seroprevalence at baseline

  • Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc

    Anti-HBs immune response at Month 1

  • Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc

    Anti-HBs immune response at Month 6

  • Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc

    Anti-HBs immune response at Month 20

Study Arms (1)

HBV vaccine

EXPERIMENTAL

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

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

Interventions

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

Eligibility Criteria

Age16 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangxi Centers for Disease Control and Prevention

Nanning, Guangxi, China

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Engerix-Bhalofantrine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 19, 2013

First Posted

May 23, 2013

Study Start

September 1, 2009

Primary Completion

November 1, 2011

Last Updated

May 24, 2013

Record last verified: 2013-05

Locations

CN(1)