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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

632 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatitis B

Interventions

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Hepatitis B vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Wilrijk, , Belgium

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Basel, , Switzerland

Site Status

Countries

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Belgium Germany Switzerland

References

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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.

Reference Type DERIVED

PMID: 19697416 (View on PubMed)

Study Documents

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