NCT01973582

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 31, 2013

Status Verified

October 1, 2013

Enrollment Period

3 years

First QC Date

October 20, 2013

Last Update Submit

October 25, 2013

Conditions

Keywords

Hepatitis Bepidemiologyyouthvaccine

Outcome Measures

Primary Outcomes (1)

  • serostatus of hepatitis B viral markers

    One year

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young adults 20 to 30 years old.

You may qualify if:

  • Young adults 20 to 30 years old.

You may not qualify if:

  • Refused to undergo blood draw or questionaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 10002, Taiwan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 20209603BACKGROUND
  • 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.

    PMID: 16782778BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, blood cells

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Chyi-Feng Jan, MD, MSc, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chyi-Feng JAN, M.D.,Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2013

First Posted

October 31, 2013

Study Start

July 1, 2011

Primary Completion

July 1, 2014

Study Completion

December 1, 2014

Last Updated

October 31, 2013

Record last verified: 2013-10

Locations