The Hepatitis B Vaccine Booster Response Among the Youth Who Had Completed Neonatal Hepatitis B Vaccines

NCT00792610 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2009-10-06

Study results available
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Summary

At the time of the present study, the necessity for booster vaccinations for the prevention of hepatitis B(HB) 15 years post-vaccination in the group of young adults who have become seronegative for HB markers after complete neonatal HB vaccination was in question. A booster vaccination strategy may lead to a significant economic impact on national health care resources, and the costs/benefits must therefore be carefully evaluated. Unfortunately, the data to support such analyses are lacking. Because an increased risk of HB infection is anticipated when adolescents enter into young adulthood through becoming sexual active, breakthrough infections such as fulminant HB might be the main concern instead of the risk of chronic HB carriage. To address this issue, this study aimed to measure the booster responses after HB vaccination in seronegative young adults who had completed neonatal HB vaccines in Taiwan before.

Conditions

Interventions

BIOLOGICAL

hepatitis B vaccine

Recombinant HBsAg, 20mcg/ml/vial (GSK) one vial IM at Day 0, Month 1, month 6 during follow-up, respectively.

Sponsors & Collaborators

  • National Science and Technology Council, Taiwan

    collaborator OTHER_GOV
  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Chyi-Feng Jan, Doctor · National Taiwan University Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
23 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-01-31
Completion
2009-02-28

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00792610 on ClinicalTrials.gov