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Qidong Hepatitis B Intervention Study

Primary Purpose

Hepatitis B, Liver Neoplasms, Liver Diseases

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Hep-V Vax

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring hepatitis B, hepatocellular carcinoma, prevention, vaccination

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria: all infants born in Qidong between September 1983 and November 1990 Exclusion Criteria: -

Sites / Locations

Qidong Liver Cancer Institute
Cancer Institute, Chinese Academy of Medical Sciences
Clinical Trial Service Unit and Epidemiological Studies Unit

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00222664

First Posted

September 13, 2005

Last Updated

September 13, 2005

Sponsor

University of Oxford

Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Qidong Liver Cancer Institute, Merck Institute for Therapeutic Research

1. Study Identification

Unique Protocol Identification Number

NCT00222664

Brief Title

Qidong Hepatitis B Intervention Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2005

Overall Recruitment Status

Completed

Study Start Date

September 1983 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Oxford

Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Qidong Liver Cancer Institute, Merck Institute for Therapeutic Research

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B, Liver Neoplasms, Liver Diseases

Keywords

hepatitis B, hepatocellular carcinoma, prevention, vaccination

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80000 (false)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Hep-V Vax

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Eligibility Criteria

Inclusion Criteria: all infants born in Qidong between September 1983 and November 1990 Exclusion Criteria: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zongtang Sun, MD

Organizational Affiliation

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Richard Peto, Msc

Organizational Affiliation

University of Oxford

Official's Role

Study Director

Facility Information:

Facility Name

Qidong Liver Cancer Institute

City

Qidong

State/Province

Jiangsu

Country

China

Facility Name

Cancer Institute, Chinese Academy of Medical Sciences

City

Beijing

Country

China

Facility Name

Clinical Trial Service Unit and Epidemiological Studies Unit

City

Oxford

ZIP/Postal Code

OX3 7LF

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

1665400

Citation

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.

Results Reference

result

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Qidong Hepatitis B Intervention Study

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