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Qidong Hepatitis B Intervention Study

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ClinicalTrials.gov Identifier: NCT00222664
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
Sponsor:
Collaborators:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Qidong Liver Cancer Institute
Merck Institute for Therapeutic Research
Information provided by:
University of Oxford

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.

Condition or disease Intervention/treatment Phase
Hepatitis B Liver Neoplasms Liver Diseases Biological: Hep-V Vax Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 80000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : September 1983
Study Completion Date : December 2004

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

all infants born in Qidong between September 1983 and November 1990

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222664


Locations
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China, Jiangsu
Qidong Liver Cancer Institute
Qidong, Jiangsu, China
China
Cancer Institute, Chinese Academy of Medical Sciences
Beijing, China
United Kingdom
Clinical Trial Service Unit and Epidemiological Studies Unit
Oxford, United Kingdom, OX3 7LF
Sponsors and Collaborators
University of Oxford
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Qidong Liver Cancer Institute
Merck Institute for Therapeutic Research
Investigators
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Study Director: Zongtang Sun, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Director: Richard Peto, Msc University of Oxford
Publications of Results:
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ClinicalTrials.gov Identifier: NCT00222664    
Other Study ID Numbers: Qidong-HBV-Study
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: August 2005
Keywords provided by University of Oxford:
hepatitis B
hepatocellular carcinoma
prevention
vaccination
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Liver Neoplasms
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Digestive System Neoplasms
Neoplasms by Site
Neoplasms