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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80,000
Qidong Liver Cancer Institute
Qidong, Jiangsu, China
Cancer Institute, Chinese Academy of Medical Sciences
Beijing, China
Clinical Trial Service Unit and Epidemiological Studies Unit
Oxford, United Kingdom
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