Persistence of the Immune Response to Hepatitis B in 7-9 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

October 11, 2016 updated by: GlaxoSmithKline

Multicentre Study to Assess Persistence of Antibodies Against Hepatitis B and Immune Response to a Hepatitis B Challenge Dose in Healthy Children 7 to 9 Years Old Previously Vaccinated With 4 Doses of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine

Persistence of seroprotective antibody concentrations & immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

350

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

  • Germany
      • Berlin, Germany, 10249
        • GSK Investigational Site
      • Berlin, Germany, 13507
        • GSK Investigational Site
      • Berlin, Germany, 13355
        • GSK Investigational Site
      • Berlin, Germany, 10999
        • GSK Investigational Site
      • Hamburg, Germany, 22415
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Ettenheim, Baden-Wuerttemberg, Germany, 77955
        • GSK Investigational Site
      • Kehl, Baden-Wuerttemberg, Germany, 77694
        • GSK Investigational Site
      • Oberkirch, Baden-Wuerttemberg, Germany, 77704
        • GSK Investigational Site
      • Offenburg, Baden-Wuerttemberg, Germany, 77654
        • GSK Investigational Site
    • Bayern
      • Aichach, Bayern, Germany, 86551
        • GSK Investigational Site
      • Bobingen, Bayern, Germany, 86399
        • GSK Investigational Site
      • Erding, Bayern, Germany, 85435
        • GSK Investigational Site
      • Kaufering, Bayern, Germany, 86916
        • GSK Investigational Site
      • Kempten, Bayern, Germany, 87435
        • GSK Investigational Site
      • Landsberg, Bayern, Germany, 86899
        • GSK Investigational Site
      • Lohr, Bayern, Germany, 97816
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81241
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81243
        • GSK Investigational Site
      • Noerdlingen, Bayern, Germany, 86720
        • GSK Investigational Site
      • Pegnitz, Bayern, Germany, 91257
        • GSK Investigational Site
      • Tutzing, Bayern, Germany, 82327
        • GSK Investigational Site
      • Weilheim, Bayern, Germany, 82362
        • GSK Investigational Site
    • Hessen
      • Marburg/Lahn, Hessen, Germany, 35039
        • GSK Investigational Site
    • Niedersachsen
      • Salzgitter, Niedersachsen, Germany, 38226
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Erkrath, Nordrhein-Westfalen, Germany, 40699
        • GSK Investigational Site
      • Krefeld, Nordrhein-Westfalen, Germany, 47798
        • GSK Investigational Site
      • Willich, Nordrhein-Westfalen, Germany, 47877
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Bad Sobernheim, Rheinland-Pfalz, Germany, 55566
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • GSK Investigational Site
      • Schoeneberg - Kuebelberg, Rheinland-Pfalz, Germany, 66901
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Germany, 54290
        • GSK Investigational Site
    • Sachsen
      • Bischofswerda, Sachsen, Germany, 01877
        • GSK Investigational Site
      • Dresden, Sachsen, Germany, 01307
        • GSK Investigational Site
    • Schleswig-Holstein
      • Altenholz, Schleswig-Holstein, Germany, 24161
        • GSK Investigational Site
      • Bredstedt, Schleswig-Holstein, Germany, 25821
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24937
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24944
        • GSK Investigational Site
      • Husum, Schleswig-Holstein, Germany, 25813
        • GSK Investigational Site
      • Kiel, Schleswig-Holstein, Germany, 24161
        • GSK Investigational Site
      • Niebuell, Schleswig-Holstein, Germany, 25899
        • GSK Investigational Site
    • Thueringen
      • Lobenstein, Thueringen, Germany, 07356
        • GSK Investigational Site
      • Rudolstadt, Thueringen, Germany, 07407
        • 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

7 years to 9 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A male or female aged 7 to 9 years at the time of study entry .
  • Subjects who have received a total of 4 doses of DTPa-HBV-IPV/Hib vaccine or a total of 4 doses of HBV vaccine in previous vaccination studies.
  • Evidence of previous hepatitis B booster vaccination or disease since administration of the fourth dose of DTPa-HBV-IPV/Hib or HBV vaccine.

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Anti-HBs antibody concentration

Secondary Outcome Measures

Outcome Measure
Persistence of antibodies to the other DTPa-HBV-IPV/Hib vaccine antigens.
Sol & unsol symptoms after HBV vaccination, SAEs

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

July 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

July 25, 2006

First Submitted That Met QC Criteria

July 25, 2006

First Posted (Estimate)

July 26, 2006

Study Record Updates

Last Update Posted (Estimate)

October 12, 2016

Last Update Submitted That Met QC Criteria

October 11, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106744

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. Informed Consent Form
    Information identifier: 106744
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Clinical Study Report
    Information identifier: 106744
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Study Protocol
    Information identifier: 106744
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individual Participant Data Set
    Information identifier: 106744
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Statistical Analysis Plan
    Information identifier: 106744
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Dataset Specification
    Information identifier: 106744
    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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