Hepatitis BNCT01973582
Hepatitis B Seroepidemiology Among Young Adults
An observational study of Hepatitis B, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- How many people
- 6,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young adults 20 to 30 years old.
Who may be able to join
- Young adults 20 to 30 years old.
Who cannot join
- Refused to undergo blood draw or questionaire.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taipei, 10002
CHYI-FENG JAN, MD, PhD, 886223123456 ext. 66824, jcf036@ntu.edu.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, epidemiology, youth, vaccine
- Medical subject headings
- Hepatitis B
What is being measured
The primary outcome is the main question the study is designed to answer.
serostatus of hepatitis B viral markers
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startJul 2011
- Primary completionJul 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chyi-Feng Jan, MD, MSc, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973582
- Sponsor's protocol ID
- 201012127RB
- Status last verified
- Oct 2013
- First submitted
- 20 Oct 2013
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20209603Chien 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.
PubMed 16782778
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study of Hepatitis B Seroepidemiology Among Young Adults
- ClinicalTrials.gov ID
- NCT01973582
- Acronym / sponsor ID
- 201012127RB
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, epidemiology, youth, vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jul 2011
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young adults 20 to 30 years old.
Key inclusion criteria (1 listed)
- Young adults 20 to 30 years old.
Key exclusion criteria (1 listed)
- Refused to undergo blood draw or questionaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serostatus of hepatitis B viral markers
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
- Background: PubMed 20209603Jan 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.
- Background: PubMed 16782778Chien 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chyi-Feng Jan, MD, MSc, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chyi-Feng JAN, M.D.,Ph.D. (886-2-23123456 ext. 66824, jcf036@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serostatus of hepatitis B viral markers (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01973582, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2013.