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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329576
• Other study ID #: 106640
• Status: Completed
• Phase: Phase 4
• First received: May 23, 2006
• Last updated: September 27, 2016
• Start date: May 2006
• Est. completion date: August 2006

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 632
• Est. completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Hepatitis B

Intervention

Biological:
• Hepatitis B vaccine

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Wilrijk
Germany	GSK Investigational Site	Muenchen	Bayern
Switzerland	GSK Investigational Site	Basel

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Germany,  Switzerland, 

External Links

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