Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.

July 2, 2018 updated by: GlaxoSmithKline

An Open, Phase IV, Single-group, Multicentre Study to Assess the Long-term Persistence of Antibodies Against Hepatitis B and the Immune Response to a Hepatitis B (HBV) Vaccine Challenge in Children Aged 7-8 Years of Age and Previously Vaccinated in Infancy With GSK Biologicals' HBV Vaccine (Engerix™-B).

The purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. 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, 10967
        • GSK Investigational Site
      • Berlin, Germany, 13055
        • GSK Investigational Site
      • Berlin, Germany, 12679
        • GSK Investigational Site
      • Berlin, Germany, 13507
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Birkenfeld, Baden-Wuerttemberg, Germany, 75217
        • GSK Investigational Site
      • Ettenheim, Baden-Wuerttemberg, Germany, 77955
        • GSK Investigational Site
      • Heidelberg, Baden-Wuerttemberg, Germany, 69120
        • GSK Investigational Site
      • Karlsruhe, Baden-Wuerttemberg, Germany, 76189
        • GSK Investigational Site
      • Oberkirch, Baden-Wuerttemberg, Germany, 77704
        • 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
      • Tuttlingen, Baden-Wuerttemberg, Germany, 78532
        • GSK Investigational Site
    • Bayern
      • Bindlach, Bayern, Germany, 95463
        • GSK Investigational Site
      • Kaufering, Bayern, Germany, 86916
        • GSK Investigational Site
      • Lohr, Bayern, Germany, 97816
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81735
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81241
        • GSK Investigational Site
      • Tegernsee, Bayern, Germany, 83684
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Loehne, Nordrhein-Westfalen, Germany, 32584
        • GSK Investigational Site
      • Minden, Nordrhein-Westfalen, Germany, 32427
        • GSK Investigational Site
      • Muenster, Nordrhein-Westfalen, Germany, 48163
        • GSK Investigational Site
      • Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Frankenthal, Rheinland-Pfalz, Germany, 67227
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Germany, 54294
        • GSK Investigational Site
      • Worms, Rheinland-Pfalz, Germany, 67547
        • GSK Investigational Site
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • GSK Investigational Site
    • Schleswig-Holstein
      • Bredstedt, Schleswig-Holstein, Germany, 25821
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24937
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24943
        • 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

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 8 years (Child)

Accepts Healthy Volunteers

No

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 7 to 8 years of age (from and including the 7th birthday up to but excluding the 9th birthday) at the time of enrolment.
  • With documented evidence of previous vaccination with three consecutive doses of Engerix™-B 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 third dose of Engerix™-B vaccine.
  • 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 HBV vaccine challenge and ending 30 days after.
  • Administration of immunoglobulins and/or any blood products within the three months preceding HBV vaccine challenge 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.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination

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 Engerix
Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
Biological: Engerix™-B Kinder
Intramuscular injection, 1 dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value
Time Frame: One month after the challenge dose of HBV vaccine
Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL)
One month after the challenge dose of HBV vaccine

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value
Time Frame: Before challenge dose of HBV vaccine
Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL
Before challenge dose of HBV vaccine
Number of Participants Reporting Solicited Local Symptoms
Time Frame: During the 4-day follow-up period after the challenge dose of HBV vaccine.
Solicited local symptoms assessed include pain, redness and swelling
During the 4-day follow-up period after the challenge dose of HBV vaccine.
Number of Participants Reporting Solicited General Symptoms
Time Frame: During the 4-day follow-up period after the challenge dose of HBV vaccine.
Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache
During the 4-day follow-up period after the challenge dose of HBV vaccine.
Number of Participants Reporting Unsolicited Adverse Events
Time Frame: During the 31-day follow-up period after the challenge dose of HBV vaccine.
An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
During the 31-day follow-up period after the challenge dose of HBV vaccine.
Number of Participants Reporting Serious Adverse Events (SAE)
Time Frame: After the challenge dose of HBV vaccine.

An SAE is any untoward medical occurrence that:

results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
After the 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

August 31, 2007

Primary Completion (Actual)

December 31, 2007

Study Completion (Actual)

December 31, 2007

Study Registration Dates

First Submitted

August 21, 2007

First Submitted That Met QC Criteria

August 21, 2007

First Posted (Estimate)

August 22, 2007

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

July 2, 2018

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110474

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. Study Protocol
    Information identifier: 110474
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Individual Participant Data Set
    Information identifier: 110474
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Informed Consent Form
    Information identifier: 110474
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Annotated Case Report Form
    Information identifier: 110474
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Statistical Analysis Plan
    Information identifier: 110474
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Clinical Study Report
    Information identifier: 110474
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Dataset Specification
    Information identifier: 110474
    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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