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Qidong Hepatitis B Intervention Study

NCT ID: NCT00222664

Last Updated: 2005-09-22

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

80000 participants

Study Classification

INTERVENTIONAL

Study Start Date

1983-09-30

Study Completion Date

2004-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis B Liver Neoplasms Liver Diseases

Keywords

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hepatitis B hepatocellular carcinoma prevention vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Hep-V Vax

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

all infants born in Qidong between September 1983 and November 1990

Exclusion Criteria

\-
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

Qidong Liver Cancer Institute

OTHER

Sponsor Role collaborator

Merck Institute for Therapeutic Research

UNKNOWN

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Principal Investigators

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Zongtang Sun, MD

Role: STUDY_DIRECTOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Richard Peto, Msc

Role: STUDY_DIRECTOR

University of Oxford

Locations

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Qidong Liver Cancer Institute

Qidong, Jiangsu, China

Site Status

Cancer Institute, Chinese Academy of Medical Sciences

Beijing, , China

Site Status

Clinical Trial Service Unit and Epidemiological Studies Unit

Oxford, , United Kingdom

Site Status

Countries

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China United Kingdom

References

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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.

Reference Type RESULT
PMID: 1665400 (View on PubMed)

Other Identifiers

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Qidong-HBV-Study

Identifier Type: -

Identifier Source: org_study_id