NCT00222664

Brief Summary

During 1983-1990 in the Jiangsu province of China, 80,000 infants were randomised by area of birth between control, standard Hepatitis B vaccination (at 0, 1 and 6 months of age) and standard vaccination plus a booster dose at about 2 to 3 years of age. The aim is to prevent establishment of chronic HBV infection in early childhood, hence to prevent the morbidity of chronic hepatitis B in young adolescents and the incidence/mortality several decades later from liver cancer and other HBV related chronic liver diseases. Long-term follow-up through central registries will determine the impact of vaccination on liver cancer incidence and mortality.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
80,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 1983

Longer than P75 for phase_4

Geographic Reach
2 countries

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1983

Completed
21.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

September 22, 2005

Status Verified

August 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Hepatitis BLiver NeoplasmsLiver Diseases

Keywords

hepatitis Bhepatocellular carcinomapreventionvaccination

Interventions

Hep-V VaxBIOLOGICAL

Eligibility Criteria

Age0 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all infants born in Qidong between September 1983 and November 1990

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Qidong Liver Cancer Institute

Qidong, Jiangsu, China

Location

Cancer Institute, Chinese Academy of Medical Sciences

Beijing, China

Location

Clinical Trial Service Unit and Epidemiological Studies Unit

Oxford, OX3 7LF, United Kingdom

Location

Related Publications (1)

  • Sun Z, Zhu Y, Stjernsward J, Hilleman M, Collins R, Zhen Y, Hsia CC, Lu J, Huang F, Ni Z, et al. Design and compliance of HBV vaccination trial on newborns to prevent hepatocellular carcinoma and 5-year results of its pilot study. Cancer Detect Prev. 1991;15(4):313-8.

    PMID: 1665400RESULT

MeSH Terms

Conditions

Hepatitis BLiver NeoplasmsLiver DiseasesCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisDigestive System DiseasesDigestive System NeoplasmsNeoplasms by SiteNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Zongtang Sun, MD

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    STUDY DIRECTOR

  • Richard Peto, Msc

    University of Oxford

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

September 1, 1983

Study Completion

December 1, 2004

Last Updated

September 22, 2005

Record last verified: 2005-08

Locations

CN(2)GB(1)