Clinical Trials Logo
  1. Home
  2. Hepatitis B
  3. NCT00222664
  4. Details
NCT00222664 Clinical Trial

Qidong Hepatitis B Intervention Study

Hepatitis B Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00222664
Other study ID # Qidong-HBV-Study
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated September 13, 2005
Start date September 1983
Est. completion date December 2004

Study information
Verified date August 2005
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80000
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

all infants born in Qidong between September 1983 and November 1990

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Hep-V Vax

Locations
Country Name City State
China Cancer Institute, Chinese Academy of Medical Sciences Beijing
China Qidong Liver Cancer Institute Qidong Jiangsu
United Kingdom Clinical Trial Service Unit and Epidemiological Studies Unit Oxford

Sponsors (4)
Lead Sponsor Collaborator
University of Oxford Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Merck Institute for Therapeutic Research, Qidong Liver Cancer Institute

Countries where clinical trial is conducted

China,  United Kingdom, 

References & Publications (1)

Sun Z, Zhu Y, Stjernsward J, Hilleman M, Collins R, Zhen Y, Hsia CC, Lu J, Huang F, Ni Z, et al. Design and compliance of HBV vaccination trial on newborns to prevent hepatocellular carcinoma and 5-year results of its pilot study. Cancer Detect Prev. 1991 — View Citation

See also
  Status Clinical Trial Phase
Completed NCT01182311 - Duration of Long-term Immunity After Hepatitis B Virus Immunization
Completed NCT04971928 - Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment Phase 1
Completed NCT03285620 - A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants Phase 1
Completed NCT01884415 - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis Phase 3
Recruiting NCT05404919 - Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates Phase 2
Completed NCT02153320 - Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers Phase 1
Completed NCT00352963 - Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age). Phase 3
Completed NCT03567382 - Arresting Vertical Transmission of Hepatitis B Virus Phase 4
Not yet recruiting NCT04056728 - A Phase IV Study to Assess the Safety of EupentaTM Inj Phase 4
Not yet recruiting NCT03604016 - Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver Phase 4
Completed NCT00753649 - Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants Phase 4
Recruiting NCT03027258 - Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome N/A
Completed NCT02540538 - Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders Phase 1
Terminated NCT02604199 - A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection Phase 2
Completed NCT02169674 - Hepatitis B Booster Study in Adolescence Phase 4
Completed NCT02421666 - A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV N/A
Completed NCT01917357 - A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject Phase 3
Completed NCT01368497 - Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection Phase 3
Completed NCT01732354 - Study for Consolidation Period of Chronic Hepatitis B
Recruiting NCT01462981 - Cohort of Hepatitis B Research of Amsterdam N/A