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Persistence of the Immune Response to Hepatitis B in 7-9 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00356564
First received: July 25, 2006
Last updated: November 10, 2011
Last verified: November 2011
History of Changes
  Purpose

Persistence of seroprotective antibody concentrations & immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine


Condition Intervention Phase
Hepatitis B
 Biological: hepatitis B vaccine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Multicentre Study to Assess Persistence of Antibodies Against Hepatitis B & Immune Response to a Hepatitis B Challenge Dose in Healthy Children 7 to 9 Yrs Old Previously Vaccinated With 4 Doses of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-HBs antibody concentration

Secondary Outcome Measures:
  • Persistence of antibodies to the other DTPa-HBV-IPV/Hib vaccine antigens.
  • Sol & unsol symptoms after HBV vaccination, SAEs

Estimated Enrollment: 350
Study Start Date: July 2006
Intervention Details:
    Biological: hepatitis B vaccine
    Other Name: hepatitis B vaccine
  Eligibility

Ages Eligible for Study:   7 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female aged 7 to 9 years at the time of study entry .
  • Subjects who have received a total of 4 doses of DTPa-HBV-IPV/Hib vaccine or a total of 4 doses of HBV vaccine in previous vaccination studies.
  • Evidence of previous hepatitis B booster vaccination or disease since administration of the fourth dose of DTPa-HBV-IPV/Hib or HBV vaccine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356564

Locations
Germany
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
GSK Investigational Site
Oberkirch, Baden-Wuerttemberg, Germany, 77704
GSK Investigational Site
Offenburg, Baden-Wuerttemberg, Germany, 77654
GSK Investigational Site
Aichach, Bayern, Germany, 86551
GSK Investigational Site
Bobingen, Bayern, Germany, 86399
GSK Investigational Site
Erding, Bayern, Germany, 85435
GSK Investigational Site
Kaufering, Bayern, Germany, 86916
GSK Investigational Site
Kempten, Bayern, Germany, 87435
GSK Investigational Site
Landsberg, Bayern, Germany, 86899
GSK Investigational Site
Lohr, Bayern, Germany, 97816
GSK Investigational Site
Muenchen, Bayern, Germany, 81241
GSK Investigational Site
Muenchen, Bayern, Germany, 81243
GSK Investigational Site
Noerdlingen, Bayern, Germany, 86720
GSK Investigational Site
Pegnitz, Bayern, Germany, 91257
GSK Investigational Site
Tutzing, Bayern, Germany, 82327
GSK Investigational Site
Weilheim, Bayern, Germany, 82362
GSK Investigational Site
Marburg/Lahn, Hessen, Germany, 35039
GSK Investigational Site
Salzgitter, Niedersachsen, Germany, 38226
GSK Investigational Site
Erkrath, Nordrhein-Westfalen, Germany, 40699
GSK Investigational Site
Krefeld, Nordrhein-Westfalen, Germany, 47798
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
GSK Investigational Site
Bad Sobernheim, Rheinland-Pfalz, Germany, 55566
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Schoeneberg - Kuebelberg, Rheinland-Pfalz, Germany, 66901
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
GSK Investigational Site
Bischofswerda, Sachsen, Germany, 01877
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Altenholz, Schleswig-Holstein, Germany, 24161
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
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
Niebuell, Schleswig-Holstein, Germany, 25899
GSK Investigational Site
Lobenstein, Thueringen, Germany, 07356
GSK Investigational Site
Rudolstadt, Thueringen, Germany, 07407
GSK Investigational Site
Berlin, Germany, 10249
GSK Investigational Site
Berlin, Germany, 10999
GSK Investigational Site
Berlin, Germany, 13355
GSK Investigational Site
Berlin, Germany, 13507
GSK Investigational Site
Hamburg, Germany, 22415
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Zinke M et al. Immune memory against hepatitis B persists in 7-9 year olds previously vaccinated with 4 doses of hexavalent DTPa-HBV-IPV/Hib vaccine. Abstract presented at the 26th annual meeting of the European Society for Paediatric Infectious Diseases (ESPID), Graz, Austria, 13-17 May 2008.

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00356564     History of Changes
Other Study ID Numbers: 106744
Study First Received: July 25, 2006
Last Updated: November 10, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
Prophylaxis for hepatitis B disease

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

ClinicalTrials.gov processed this record on June 18, 2013