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Persistence of the Immune Response to Hepatitis B in 4-6 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00335881
First received: June 9, 2006
Last updated: October 6, 2016
Last verified: October 2016
  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 4 to 6 Years Old Previously Vaccinated With 4 Doses of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine

Resource links provided by NLM:


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: 300
Study Start Date: June 2006
Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   4 Years to 6 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female aged 4 to 6 years at the time of study entry .
  • Subjects who have received a total of 4 doses of DTPa-HBV-IPV/Hib 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 vaccine.
  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: NCT00335881

Locations
Germany
GSK Investigational Site
Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
GSK Investigational Site
Boennigheim, Baden-Wuerttemberg, Germany, 74357
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
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
GSK Investigational Site
Tuttlingen, Baden-Wuerttemberg, Germany, 78532
GSK Investigational Site
Cham, Bayern, Germany, 93413
GSK Investigational Site
Freising, Bayern, Germany, 85354
GSK Investigational Site
Kaufering, Bayern, Germany, 86916
GSK Investigational Site
Landsberg, Bayern, Germany, 86899
GSK Investigational Site
Muenchen, Bayern, Germany, 80939
GSK Investigational Site
Muenchen, Bayern, Germany, 81241
GSK Investigational Site
Muenchen, Bayern, Germany, 81735
GSK Investigational Site
Noerdlingen, Bayern, Germany, 86720
GSK Investigational Site
Tutzing, Bayern, Germany, 82327
GSK Investigational Site
Weilheim, Bayern, Germany, 82362
GSK Investigational Site
Waren, Mecklenburg-Vorpommern, Germany, 17192
GSK Investigational Site
Salzgitter, Niedersachsen, Germany, 38226
GSK Investigational Site
Erkrath, Nordrhein-Westfalen, Germany, 40699
GSK Investigational Site
Heiligenhaus, Nordrhein-Westfalen, Germany, 42579
GSK Investigational Site
Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
GSK Investigational Site
Krefeld, Nordrhein-Westfalen, Germany, 47798
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
GSK Investigational Site
Schoeneberg - Kuebelberg, Rheinland-Pfalz, Germany, 66901
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54294
GSK Investigational Site
Altenholz, Schleswig-Holstein, Germany, 24161
GSK Investigational Site
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
Berlin, Germany, 10315
GSK Investigational Site
Berlin, Germany, 12627
GSK Investigational Site
Berlin, Germany, 13355
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 106745
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 106745
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 106745
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 106745
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 106745
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 106745
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00335881     History of Changes
Other Study ID Numbers: 106745 
Study First Received: June 9, 2006
Last Updated: October 6, 2016
Health Authority: Germany: Paul-Ehrlich-Institut
Individual Participant Data  
Plan to Share IPD: Yes
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.

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016