Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Long-Term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.
This study has been completed.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00519649
  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
Biological: Engerix™-B Kinder
Phase IV

MedlinePlus related topics: Hepatitis Hepatitis B
Drug Information available for: Hepatitis B Vaccines Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-hepatitis B surface antigen (HBs) antibody concentrations [ Time Frame: One month after the challenge dose of HBV vaccine ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anti-HBs antibody concentrations [ Time Frame: Before challenge dose of HBV vaccine ] [ Designated as safety issue: No ]
  • Occurrence of solicited local symptoms [ Time Frame: During the 4-day follow-up period after the challenge dose of HBV vaccine. ] [ Designated as safety issue: Yes ]
  • Occurrence of solicited general symptoms [ Time Frame: During the 4-day follow-up period after the challenge dose of HBV vaccine. ] [ Designated as safety issue: Yes ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after the challenge dose of HBV vaccine. ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events [ Time Frame: After the challenge dose of HBV vaccine. ] [ Designated as safety issue: Yes ]

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
Group A: Experimental 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

Locations
Germany
GSK Investigational Site
Berlin, Germany, 10967
GSK Investigational Site
Berlin, Germany, 13055
Germany, Baden-Wuerttemberg
GSK Investigational Site
Oberstenfeld, Baden-Wuerttemberg, Germany, 71720
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
GSK Investigational Site
Tuttlingen, Baden-Wuerttemberg, Germany, 78532
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
GSK Investigational Site
Karlsruhe, Baden-Wuerttemberg, Germany, 76189
GSK Investigational Site
Offenburg, Baden-Wuerttemberg, Germany, 77654
GSK Investigational Site
Pforzheim, Baden-Wuerttemberg, Germany, 75172
Germany, Bayern
GSK Investigational Site
Lohr, Bayern, Germany, 97816
GSK Investigational Site
Bindlach, Bayern, Germany, 95463
GSK Investigational Site
Tegernsee, Bayern, Germany, 83684
Germany, Nordrhein-Westfalen
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
Germany, Rheinland-Pfalz
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67547
Germany, Schleswig-Holstein
GSK Investigational Site
Bredstedt, Schleswig-Holstein, Germany, 25821
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24943
GSK Investigational Site
Husum, Schleswig-Holstein, Germany, 25813
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24161
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: 110474
Study First Received: August 21, 2007
Last Updated: November 6, 2008
ClinicalTrials.gov Identifier: NCT00519649  
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
Challenge dose
Hepatitis B vaccine

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Antibodies
Liver Diseases
Digestive System Diseases
Hepatitis B Antibodies
Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections
Immunoglobulins

Additional relevant MeSH terms:
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 15, 2009