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Evaluate Immune Response Approximately 5 to 6 Years After Receiving Different Formulations of GSK Bio Hep B Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00329576
First received: May 23, 2006
Last updated: September 27, 2016
Last verified: September 2016
  Purpose
To evaluate the persistence of antibodies against hepatitis B, approximately 5 to 6 years after the first dose of the hepatitis B in the primary vaccination study.

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

Study Type: Interventional
Official Title: Evaluate the Anti-HBs Antibody Persistence, in Subjects Who Received GSK Biologicals' Preservative-free or Thiomersal-free Engerix™-B or Engerix™-B Containing Thiomersal, Approximately 5 to 6 Yrs Earlier

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Estimated Enrollment: 632
Study Start Date: May 2006
Study Completion Date: August 2006
Detailed Description:
All subjects who participated in the primary vaccination study, where subjects who received GSK Biologicals' hepatitis B vaccine and who will consent to participate in this long-term follow-up study, approximately 5 to 6 years after the primary vaccination study. The study will be conducted in only 3 centres out of the 4 centres in the primary vaccination study.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects should have participated in the primary study and should have received the first primary dose of vaccination more than five years ago and less than six years ago before blood sampling in this long-term follow-up study.
  • Written informed consent obtained from the subject for the long-term follow-up.
  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: NCT00329576

Locations
Belgium
GSK Investigational Site
Wilrijk, Belgium, 2610
Germany
GSK Investigational Site
Muenchen, Bayern, Germany, 80799
Switzerland
GSK Investigational Site
Basel, Switzerland, 4002
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 106640
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 106640
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 106640
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: 106640
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: 106640
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: NCT00329576     History of Changes
Other Study ID Numbers: 106640 
Study First Received: May 23, 2006
Last Updated: September 27, 2016
Health Authority: Switzerland: Swissmedic
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.

Additional relevant MeSH terms:
Hepatitis B
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016