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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.
Information provided by:
GlaxoSmithKline Identifier:
First received: May 23, 2006
Last updated: September 29, 2011
Last verified: September 2011
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
Prophylaxis 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
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.

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

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
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Please refer to this study by its identifier: NCT00329576

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00329576     History of Changes
Other Study ID Numbers: 106640 
Study First Received: May 23, 2006
Last Updated: September 29, 2011
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Hepatitis B
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on September 27, 2016