MedTrace Logo

Qidong Hepatitis B Intervention Study

NCT00222664 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80000

Last updated 2005-09-22

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Hep-V Vax

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    collaborator OTHER

  • Qidong Liver Cancer Institute

    collaborator OTHER

  • Merck Institute for Therapeutic Research

    collaborator UNKNOWN

  • University of Oxford

    lead OTHER

Principal Investigators

  • Zongtang Sun, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Richard Peto, Msc · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1983-09-30
Completion
2004-12-31

Countries

  • China
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00222664 on ClinicalTrials.gov