Qidong Hepatitis B Intervention Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00222664

Enrollment

80000

Registered

2005-09-22

Start date

1983-09-30

Completion date

2004-12-31

Last updated

2005-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Liver Diseases, Liver Neoplasms

Keywords

hepatitis B, hepatocellular carcinoma, prevention, vaccination

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.

Interventions

BIOLOGICALHep-V Vax

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Years to No maximum

Inclusion criteria

all infants born in Qidong between September 1983 and November 1990

Exclusion criteria

Countries

China, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026