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Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers

NCT00240500 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2016-12-21

Study results available
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Summary

The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Interventions

BIOLOGICAL

Engerix™-B

In the primary study, subjects received HBV (10 milligram) vaccine according to a 0, 1 and 2 month schedule with a booster dose at Month 12. Subjects in the 5-dose vaccination regimen received a booster dose of HBV vaccine at Month 60.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • Thailand

Study Locations

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Entities

Diseases
Companies

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 NCT00240500 on ClinicalTrials.gov