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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014