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Hepatitis B Seroepidemiology Among Young Adults

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ClinicalTrials.gov Identifier: NCT01973582
Recruitment Status : Unknown
Verified October 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : October 31, 2013
Last Update Posted : October 31, 2013
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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. 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.

Condition or disease
Hepatitis B

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.

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Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Retrospective Cohort Study of Hepatitis B Seroepidemiology Among Young Adults
Study Start Date : July 2011
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. serostatus of hepatitis B viral markers [ Time Frame: One year ]

Biospecimen Retention:   Samples Without DNA
Serum, blood cells


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Young adults 20 to 30 years old.
Criteria

Inclusion Criteria:

  • Young adults 20 to 30 years old.

Exclusion Criteria:

  • Refused to undergo blood draw or questionaire.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973582


Contacts
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Contact: Chyi-Feng JAN, M.D.,Ph.D. 886-2-23123456 ext 66824 jcf036@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: CHYI-FENG JAN, MD, PhD    886223123456 ext 66824    jcf036@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
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Principal Investigator: Chyi-Feng Jan, MD, MSc, PhD National Taiwan University Hospital

Publications:
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01973582     History of Changes
Other Study ID Numbers: 201012127RB
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: October 31, 2013
Last Verified: October 2013

Keywords provided by National Taiwan University Hospital:
Hepatitis B
epidemiology
youth
vaccine

Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections