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Sponsors and Collaborators: |
University of Oxford Chinese Academy of Sciences Qidong Liver Cancer Institute Merck Institute for Therapeutic Research |
Information provided by: | University of Oxford |
ClinicalTrials.gov Identifier: | NCT00222664 |
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.
Condition | Intervention | Phase |
Hepatitis B Liver Neoplasms Liver Diseases |
Biological: Hep-V Vax |
Phase IV |
MedlinePlus related topics: | Cancer Hepatitis Hepatitis B Liver Cancer Liver Diseases |
ChemIDplus related topics: | Hepatitis B Vaccines |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Genders Eligible for Study: | Both |
Inclusion Criteria:
all infants born in Qidong between September 1983 and November 1990
Exclusion Criteria:
-
China | |||||
Cancer Institute, Chinese Academy of Medical Sciences | |||||
Beijing, China | |||||
China, Jiangsu | |||||
Qidong Liver Cancer Institute | |||||
Qidong, Jiangsu, China | |||||
United Kingdom | |||||
Clinical Trial Service Unit and Epidemiological Studies Unit | |||||
Oxford, United Kingdom, OX3 7LF |
University of Oxford |
Chinese Academy of Sciences |
Qidong Liver Cancer Institute |
Merck Institute for Therapeutic Research |
Study Director: | Zongtang Sun, MD | Chinese Academy of Sciences |
Study Director: | Richard Peto, Msc | University of Oxford |
Study ID Numbers: | Qidong-HBV-Study |
First Received: | September 13, 2005 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00222664 |
Health Authority: | China: Ministry of Health |
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