- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01973582
Hepatitis B Seroepidemiology Among Young Adults
October 25, 2013 updated by: National Taiwan University Hospital
A Retrospective Cohort Study of Hepatitis B Seroepidemiology Among Young Adults
Taiwan has launched a successful nationwide neonatal hepatitis B immunization since July 1, 1984.
It successfully decreased the incidence of hepatitis B virus infection, the hepatitis B carrier rate as well as liver diseases among children and adolescents.
The sexual transmission route is another important way of hepatitis B infection aside from the mother and child vertical infection, especially for youth and adults.
Hepatitis B vaccination cohort refers to those who were born after 1986 and received hepatitis B vaccine immunization during newborn period.
They are gradually entering into young adults and adolescent age.
Among them, there is no empirical evidence to show the actual infection rate and to help implement hepatitis B vaccine booster policy for those who had three seronegative viral markers of hepatitis B. Therefore, the study design is to collect three consecutive years graduate school students school entry health examination data and undergo three hepatitis B viral markers checkup and blood types.
The data linkage includes their health checkup data in the freshmen period, Taiwan CDC databank for neonatal hepatitis B immunization records, pregnancy and birth record registry, Taiwan cancer registry and Taiwan death record registry.
Study Overview
Status
Unknown
Conditions
Detailed Description
This study is aimed to delineate the hepatitis B seroepidemiology among young adults with or without neonatal hepatitis B immunization, among young adults with hepatitis B booster in the university period, among the mothers of hepatitis B vaccination cohort.
The results of this study will provide important information to help government implement hepatitis B vaccine booster policy in the adolescents and young adults.
Study Type
Observational
Enrollment (Anticipated)
6000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Taipei, Taiwan, 10002
- Recruiting
- National Taiwan University Hospital
-
Contact:
- CHYI-FENG JAN, MD, PhD
- Phone Number: 66824 886223123456
- Email: jcf036@ntu.edu.tw
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Young adults 20 to 30 years old.
Description
Inclusion Criteria:
- Young adults 20 to 30 years old.
Exclusion Criteria:
- Refused to undergo blood draw or questionaire.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
serostatus of hepatitis B viral markers
Time Frame: One year
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Chyi-Feng Jan, MD, MSc, PhD, National Taiwan University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chien YC, Jan CF, Kuo HS, Chen CJ. Nationwide hepatitis B vaccination program in Taiwan: effectiveness in the 20 years after it was launched. Epidemiol Rev. 2006;28:126-35. doi: 10.1093/epirev/mxj010. Epub 2006 Jun 16.
- Jan CF, Huang KC, Chien YC, Greydanus DE, Davies HD, Chiu TY, Huang LM, Chen CJ, Chen DS. Determination of immune memory to hepatitis B vaccination through early booster response in college students. Hepatology. 2010 May;51(5):1547-54. doi: 10.1002/hep.23543.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Anticipated)
July 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
October 20, 2013
First Submitted That Met QC Criteria
October 25, 2013
First Posted (Estimate)
October 31, 2013
Study Record Updates
Last Update Posted (Estimate)
October 31, 2013
Last Update Submitted That Met QC Criteria
October 25, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201012127RB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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