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

November 3, 2016 updated by: GlaxoSmithKline

Long-Term Follow Up Study at Years 16-20, to Evaluate the Persistence of Immune Response of GlaxoSmithKline Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary study was designed to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine in newborns of HBeAg+ and HBsAg+ mothers in comparison with a historical control group.

The present study is carried out to evaluate the anti-HBs persistence 16-20 years after the first vaccine dose and to further investigate the prevalence and incidence of other hepatitis B markers and the clinical significance of these at all time points from Year 16-20.

No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who had received at least one dose of the study vaccine in the primary study (103860/064)
  • Written informed consent obtained from each subject before each blood sampling visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HBV-1 Group
neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
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.
Experimental: HBV-2 Group
neonates born to HBsAg+ and HBeAg+ mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
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.
Experimental: HBV-3 Group
neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
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.
Experimental: HBV-4 Group
neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
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.
Experimental: HBV-5 Group
neonates born to HBsAg- and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
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.
Experimental: HBV-6 Group
neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
Time Frame: Years 17, 18, 19 and 20.
During this follow-up study, it was planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Therefore, the table presents mean concentrations expressed in milli-international units/milliliter (mIU/mL) at years 17, 18, 19 and 20.
Years 17, 18, 19 and 20.
Prevalence of Serological Markers for Hepatitis B Infection
Time Frame: Years 17, 18, 19 and 20.
It was initially planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Only the subjects positive for HBsAg or anti Hepatitis B core antigen (anti-HBc) were tested for HBeAg & anti-HBe
Years 17, 18, 19 and 20.
Clinical Review for Hepatitis B Infection Status
Time Frame: Over the entire 4 year follow up period (17 - 20 years)
Chronic hepatitis B (HB) carrier is defined as positive for anti-HBc AND HBsAg at two or more consecutive time points
Over the entire 4 year follow up period (17 - 20 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

October 13, 2005

First Submitted That Met QC Criteria

October 17, 2005

First Posted (Estimate)

October 18, 2005

Study Record Updates

Last Update Posted (Estimate)

December 21, 2016

Last Update Submitted That Met QC Criteria

November 3, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100448

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Clinical Study Report
    Information identifier: 100448
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Dataset Specification
    Information identifier: 100448
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Study Protocol
    Information identifier: 100448
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informed Consent Form
    Information identifier: 100448
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individual Participant Data Set
    Information identifier: 100448
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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