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NCT00222664 Clinical Trial

Qidong Hepatitis B Intervention Study

Hepatitis B Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00222664
Other study ID # Qidong-HBV-Study
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated September 13, 2005
Start date September 1983
Est. completion date December 2004

Study information
Verified date August 2005
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80000
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

all infants born in Qidong between September 1983 and November 1990

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

Intervention

Biological:
• Hep-V Vax

Locations
Country Name City State
China Cancer Institute, Chinese Academy of Medical Sciences Beijing
China Qidong Liver Cancer Institute Qidong Jiangsu
United Kingdom Clinical Trial Service Unit and Epidemiological Studies Unit Oxford

Sponsors (4)
Lead Sponsor Collaborator
University of Oxford Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Merck Institute for Therapeutic Research, Qidong Liver Cancer Institute

Countries where clinical trial is conducted

China,  United Kingdom, 

References & 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 — View Citation

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