Qidong Hepatitis B Intervention Study | NCT00222664

Studies
Qidong Hepatitis B Intervention Study

NCT00222664

Sponsor

University of Oxford

Status

Completed

Last Update Posted

Sep 22, 2005Estimated

Enrollment

80,000

Phase

Phase 4

Conditions

Hepatitis B
Liver Neoplasms
Liver Diseases

Interventions

Hep-V Vax

Countries

China
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1983

Primary Completion Date

Not provided

Completion Date

Dec 2004

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2005

Last Update Posted Date

Sep 22, 2005Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of OxfordOTHER

Collaborators

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

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80,000

Name	Type	Description	Arm Group Labels	Other Names
Hep-V Vax	Biological

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all infants born in Qidong between September 1983 and November 1990

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zongtang Sun, MD	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Study Director
Richard Peto, Msc	University of Oxford	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Qidong Liver Cancer Institute		Qidong	Jiangsu		China
Cancer Institute, Chinese Academy of Medical Sciences

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
1665400	Result	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;15(4):313-8.

ID	Term
D006509	Hepatitis B
D008113	Liver Neoplasms
D008107	Liver Diseases
D006528	Carcinoma, Hepatocellular

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections