Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine Challenge

October 27, 2016 updated by: GlaxoSmithKline

Assess Long-term Persistence of Hepatitis B Antibodies & Immune Response to a Hepatitis B Vaccine (Engerix-B Kinder) Challenge in Children Aged 4-5 Years (Previously Primed & Boosted in the 1st 2 Years of Life With DTPa-HBV-IPV/Hib Vaccine)

The purpose of this study is to determine at 5 years of age the persistence of immunity to hepatitis B that was conferred by infant vaccination with Infanrix hexa™.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

301

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, 10315
        • GSK Investigational Site
      • Berlin, Germany, 10967
        • GSK Investigational Site
      • Berlin, Germany, 13055
        • GSK Investigational Site
      • Berlin, Germany, 12679
        • GSK Investigational Site
      • Berlin, Germany, 13507
        • GSK Investigational Site
      • Berlin, Germany, 14197
        • GSK Investigational Site
      • Berlin, Germany, 13355
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
        • GSK Investigational Site
      • Bietigheim/Bissingen, Baden-Wuerttemberg, Germany, 74321
        • GSK Investigational Site
      • Boennigheim, Baden-Wuerttemberg, Germany, 74357
        • GSK Investigational Site
      • Ehingen, Baden-Wuerttemberg, Germany, 89584
        • GSK Investigational Site
      • Ettenheim, Baden-Wuerttemberg, Germany, 77955
        • GSK Investigational Site
      • Herbolzheim, Baden-Wuerttemberg, Germany, 79336
        • GSK Investigational Site
      • Kehl, Baden-Wuerttemberg, Germany, 77694
        • GSK Investigational Site
      • Kirchzarten, Baden-Wuerttemberg, Germany, 79199
        • GSK Investigational Site
      • Oberstenfeld, Baden-Wuerttemberg, Germany, 71720
        • GSK Investigational Site
      • Offenburg, Baden-Wuerttemberg, Germany, 77654
        • GSK Investigational Site
      • Pforzheim, Baden-Wuerttemberg, Germany, 75172
        • GSK Investigational Site
      • Stuttgart, Baden-Wuerttemberg, Germany, 70469
        • GSK Investigational Site
      • Tettnang, Baden-Wuerttemberg, Germany, 88069
        • GSK Investigational Site
      • Tuttlingen, Baden-Wuerttemberg, Germany, 78532
        • GSK Investigational Site
    • Bayern
      • Aschaffenburg, Bayern, Germany, 63739
        • GSK Investigational Site
      • Cham, Bayern, Germany, 93413
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81735
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81241
        • GSK Investigational Site
      • Noerdlingen, Bayern, Germany, 86720
        • GSK Investigational Site
      • Olching, Bayern, Germany, 82140
        • GSK Investigational Site
      • Tegernsee, Bayern, Germany, 83684
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Dudenhofen, Rheinland-Pfalz, Germany, 67373
        • GSK Investigational Site
      • Frankenthal, Rheinland-Pfalz, Germany, 67227
        • GSK Investigational Site
      • Gau-Odernheim, Rheinland-Pfalz, Germany, 55239
        • GSK Investigational Site
      • Gerolstein, Rheinland-Pfalz, Germany, 54568
        • GSK Investigational Site
      • Schoeneberg - Kuebelberg, Rheinland-Pfalz, Germany, 66901
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Germany, 54290
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Germany, 54294
        • GSK Investigational Site
    • Sachsen
      • Leipzig, Sachsen, Germany, 04317
        • 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

4 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
  • A male or female of 4 to 5 years of age at the time of enrolment.
  • With documented evidence of previous vaccination with four consecutive doses of Infanrix hexa™ in Germany.
  • Written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product .
  • Evidence of previous hepatitis B booster vaccination since administration of the fourth dose of Infanrix hexa™ booster in the second year of life.
  • History of or intercurrent hepatitis B disease.
  • Hepatitis B vaccination at birth.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before booster vaccination and ending 30 days after.
  • Administration of immunoglobulins and/or any blood products within the three months preceding booster vaccination or planned administration during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the HBV vaccine challenge.

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Biological: Engerix™-B Kinder
Intramuscular injection, 1 dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-hepatitis B surface antigen (HBs) antibody concentrations
Time Frame: One month after the challenge dose of HBV vaccine
One month after the challenge dose of HBV vaccine

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of serious adverse events
Time Frame: During the entire study period.
During the entire study period.
Anti-HBs antibody concentrations
Time Frame: Before and after challenge dose of HBV vaccine
Before and after challenge dose of HBV vaccine

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

December 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

December 13, 2006

First Submitted That Met QC Criteria

December 13, 2006

First Posted (Estimate)

December 14, 2006

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106789

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: 106789
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistical Analysis Plan
    Information identifier: 106789
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: 106789
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Clinical Study Report
    Information identifier: 106789
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Dataset Specification
    Information identifier: 106789
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Study Protocol
    Information identifier: 106789
    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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