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Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00289718
First received: February 9, 2006
Last updated: October 27, 2011
Last verified: October 2011
History of Changes
  Purpose

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 years after subjects received their first dose of a 3 dose 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 to 15.


Condition Intervention Phase
Hepatitis B
Hepatitis A
 Biological: Twinrix™ adult
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Long-term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration [ Time Frame: Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination ] [ Designated as safety issue: No ]
    Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL).

  • Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration [ Time Frame: Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination ] [ Designated as safety issue: No ]
    Concentrations given as GMC expressed as mIU/mL.


Secondary Outcome Measures:
  • Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration [ Time Frame: Before the additional dose and 1 month after the additional dose ] [ Designated as safety issue: No ]

    Concentrations given as GMC expressed as mIU/mL.

    If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.


  • Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration [ Time Frame: Before the additional dose and 1 month after the additional dose ] [ Designated as safety issue: No ]

    If a subject became seronegative (< 10 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.

    Only 1 subject was offered an additional dose and therefore the values obtained for this subject have been provided. Because only 1 subject was included it was not possible to provide a mean/median and a measure of dispersion.


  • Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigators as Related to Vaccination or to Study Procedures or Lack of Efficacy [ Time Frame: Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination ] [ Designated as safety issue: No ]
    An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above

  • Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period after additional vaccination ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed include pain, redness and swelling.

  • Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period after additional vaccination ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache

  • Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: During the 30-day follow-up period after additional vaccination ] [ Designated as safety issue: No ]
    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product

  • Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: During the follow-up period after additional vaccination (minimum 30 days) ] [ Designated as safety issue: No ]
    An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above


Enrollment: 51
Study Start Date: November 2004
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Twinrix Group

Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.

As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up

 Biological: Twinrix™ adult
Intramuscular administration
Other Name: Twinrix™ adult

Detailed Description:

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, 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 during the course of this long-term 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects participating in this study should have received three-dose primary vaccination with combined hepatitis A/hepatitis B vaccine in the primary study.
  • Written informed consent will be obtained from each subject before the blood sampling visit of each year
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289718

Locations
Belgium
GSK Investigational Site
Gent, Belgium, 9000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00289718     History of Changes
Other Study ID Numbers: 100556 (Y11), 100557 (Y12), 100558 (Y13), 100559 (Y14), 100560 (Y15)
Study First Received: February 9, 2006
Results First Received: January 11, 2010
Last Updated: October 27, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Combined Hepatitis A and B vaccine
Hepatitis A
Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on June 18, 2013