Qidong Hepatitis B Intervention Study

Phase 4

Completed

• Conditions: Hepatitis B; Liver Neoplasms; Liver Diseases

• Registration Number: NCT00222664
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1983-09
• Study Completion: 2004-12
• Status Verified: 2005-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Last Update Submitted: 2005-09-13
• Study First Posted: 2005-09-22
• Last Update Posted: 2005-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80000

Inclusion Criteria

all infants born in Qidong between September 1983 and November 1990

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (3)

Cancer Institute, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China

Qidong Liver Cancer Institute; 🇨🇳 Qidong, Jiangsu, China

Clinical Trial Service Unit and Epidemiological Studies Unit; 🇬🇧 Oxford, United Kingdom