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

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00329576

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
Prophylaxis Hepatitis B	Biological: Hepatitis B vaccine

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines Immunoglobulins Globulin, Immune Thimerosal

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329576

Locations

Belgium
GSK Investigational Site
Wilrijk, Belgium, 2610
Germany, Bayern
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

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	106640
Study First Received:	May 23, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00329576
Health Authority:	Switzerland: Swissmedic

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Antibodies
Liver Diseases
Digestive System Diseases

Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections
Immunoglobulins

Additional relevant MeSH terms:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 15, 2009