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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on October 02, 2014