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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00519649
First received: August 21, 2007
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatitis B Vaccine
 Biological: Engerix™-B Kinder
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Long-term Persistence of Hepatitis B Antibodies & Immune Response to a Hepatitis B Vaccine Challenge in 7-8 Year Old Children, Previously Vaccinated in Infancy With GlaxoSmithKline (GSK) Biologicals' HBV Vaccine.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL)


Secondary Outcome Measures:
  • Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value [ Time Frame: Before challenge dose of HBV vaccine ] [ Designated as safety issue: No ]
    Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL

  • Number of Participants Reporting Solicited Local Symptoms [ Time Frame: During the 4-day follow-up period after the challenge dose of HBV vaccine. ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed include pain, redness and swelling

  • Number of Participants Reporting Solicited General Symptoms [ Time Frame: During the 4-day follow-up period after the challenge dose of HBV vaccine. ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache

  • Number of Participants Reporting Unsolicited Adverse Events [ Time Frame: During the 31-day follow-up period after the challenge dose of HBV vaccine. ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Reporting Serious Adverse Events (SAE) [ Time Frame: After the challenge dose of HBV vaccine. ] [ Designated as safety issue: No ]

    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.



Enrollment: 301
Study Start Date: August 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group Engerix
Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
 Biological: Engerix™-B Kinder
Intramuscular injection, 1 dose

  Eligibility

Ages Eligible for Study:   7 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519649

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Disselhoff J et al. Immune memory against hepatitis B persists in 7-8 year olds primed with 3 doses of HBV vaccine in routine clinical practice. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00519649     History of Changes
Other Study ID Numbers: 110474
Study First Received: August 21, 2007
Results First Received: December 17, 2008
Last Updated: March 14, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
Hepatitis B vaccine
Challenge dose

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis B Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013