Qidong Hepatitis B Intervention Study

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.

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Key information

Conditions

Hepatitis B Adenocarcinoma Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Virus Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Qidong Liver Cancer Institute, Qidong, Jiangsu, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

all infants born in Qidong between September 1983 and November 1990

Exclusion criteria

Treatment and study plan

Hep-V Vax

Biological

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

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

Registry information

Important dates

Study start: 1983
Study completion: 2004
First posted: Sep 22, 2005
Registry last updated: Sep 22, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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