Long-term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Mth Schedule in Healthy Adults

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-01

Study Completion Date

2004-12-20

Brief Summary

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The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 after subjects received their first dose of a 3 dose primary vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

This protocol posting deals with objectives \& outcome measures of the extension phase at Year 11-15.

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Detailed Description

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This is a long-term follow-up study at Years 11, 12, 13, 14 and 15 after primary vaccination with GSK Biologicals' hepatitis A/hepatitis B vaccine (three-dose schedule with 3 different lots). To evaluate the long-term antibody persistence, volunteers will be bled at Years 11, 12, 13, 14 and 15 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.

No additional subjects will be recruited in the course of this extension study. If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 11, 12, 13, 14 or 15), he/ she will be offered an additional vaccine dose.

Conditions

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Hepatitis B Hepatitis A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group A

Was vaccinated with Lot A in the primary study.

Group Type EXPERIMENTAL

Twinrix™

Intervention Type BIOLOGICAL

Intramuscular injection, 3 doses

Group B

Was vaccinated with Lot B in the primary study.

Group Type EXPERIMENTAL

Twinrix™

Intervention Type BIOLOGICAL

Intramuscular injection, 3 doses

Group C

Was vaccinated with Lot C in the primary study.

Group Type EXPERIMENTAL

Twinrix™

Intervention Type BIOLOGICAL

Intramuscular injection, 3 doses

Interventions

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Twinrix™

Intramuscular injection, 3 doses

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects who had consented to participate in the long-term follow-up studies at the previous long-term blood sampling time points
* Written informed consent will have been obtained from each subject. before the blood sampling visit of each year.

Minimum Eligible Age

18 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

Countries

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Belgium

References

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Van Damme P, Leroux-Roels G, Crasta P, Messier M, Jacquet JM, Van Herck K. Antibody persistence and immune memory in adults, 15 years after a three-dose schedule of a combined hepatitis A and B vaccine. J Med Virol. 2012 Jan;84(1):11-7. doi: 10.1002/jmv.22264. Epub 2011 Nov 3.

Reference Type BACKGROUND

PMID: 22052690 (View on PubMed)

Van Damme P, Leroux-Roels G, Law B, Diaz-Mitoma F, Desombere I, Collard F, Tornieporth N, Van Herck K. Long-term persistence of antibodies induced by vaccination and safety follow-up, with the first combined vaccine against hepatitis A and B in children and adults. J Med Virol. 2001 Sep;65(1):6-13.

Reference Type BACKGROUND

PMID: 11505437 (View on PubMed)

Van Herck K, Leroux-Roels G, Van Damme P, Srinivasa K, Hoet B. Ten-year antibody persistence induced by hepatitis A and B vaccine (Twinrix) in adults. Travel Med Infect Dis. 2007 May;5(3):171-5. doi: 10.1016/j.tmaid.2006.07.003. Epub 2006 Sep 20.

Reference Type BACKGROUND

PMID: 17448944 (View on PubMed)

Study Documents

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Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 100551 are summarised with studies 100552, 100553, 100554, and 100555 on the GSK Clinical Study Register.

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