Evaluate Immune Response Approximately 5 to 6 Years After Receiving Different Formulations of GSK Bio Hep B Vaccine
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
1 other identifier
interventional
632
3 countries
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2006
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 23, 2006
CompletedFirst Posted
Study publicly available on registry
May 24, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedSeptember 28, 2016
September 1, 2016
May 23, 2006
September 27, 2016
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (3)
GSK Investigational Site
Wilrijk, 2610, Belgium
GSK Investigational Site
Munich, Bavaria, 80799, Germany
GSK Investigational Site
Basel, 4002, Switzerland
Related Publications (1)
Van Damme P, von Sonnenburg F, Hatz C, Hoet B, Lefevre I, Leyssen M. Long-term immunogenicity of preservative-free hepatitis B vaccine formulations in adults. J Med Virol. 2009 Oct;81(10):1710-5. doi: 10.1002/jmv.21568.
PMID: 19697416DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2006
First Posted
May 24, 2006
Study Start
May 1, 2006
Study Completion
August 1, 2006
Last Updated
September 28, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.