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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00289744
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 6, 7, 8, 9 and 10 after subjects received their first two doses primary vaccination schedule of combined hepatitis A/hepatitis B vaccine.

This protocol posting deals with objectives & outcome measures of the extension phase at year 6 through to 10.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Hepatitis B
Hepatitis A
Biological: TWINRIX™ ADULT
Biological: Engerix TM
Phase 3

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

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 6, 7, 8, 9, and 10. ] [ Designated as safety issue: No ]
  • Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration [ Time Frame: At Year 6, 7, 8, 9 and 10 ] [ Designated as safety issue: No ]
  • Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration [ Time Frame: Before and 1 month after the additional dose administration ] [ Designated as safety issue: No ]
  • Number of Subjects With Immune Response to the Additional Dose of Engerix™-B [ Time Frame: One month after the additional dose administration ] [ Designated as safety issue: No ]

    Immune response was defined as:

    • anti-hepatitis B surface antigen (anti-HBs) antibody concentration equal or above to 10 milli-international units per milliliter (mIU/mL) at 1 month post-challenge dose in subjects seronegative at the pre-challenge time-points
    • at least a 4-fold increase in anti-HBs antibody concentrations at 1 month post-challenge dose in subjects seropositive at the pre-challenge time-points.

  • Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy [ Time Frame: At Year 6, 7, 8, 9 and 10 ] [ Designated as safety issue: No ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

  • Number of Subjects Reporting Solicited Local and General Symptoms [ Time Frame: During the 4-day follow-up period after additional dose ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, fever, gatrointestinal symptoms and headache.

  • Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: During the 30-day follow-up period after additional dose ] [ Designated as safety issue: No ]
    Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: During the 30-day follow-up period after additional dose ] [ Designated as safety issue: No ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.


Enrollment: 171
Study Start Date: February 2004
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Twinrix Group
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix in the primary study (208127/076)
Biological: TWINRIX™ ADULT
2 doses IM injection in primary study
Other Name: TWINRIX™ ADULT
Experimental: Engerix-B Additional Dose (Adult)
Subjects aged 16 years and above who received an additional dose of EngerixTM-B (adult dose).
Biological: Engerix TM
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 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.
Experimental: Engerix-B Additional Dose (Pediatric)
Subjects under the age of 16 years who received an additional dose of EngerixTM-B (pediatric dose).
Biological: Engerix TM
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 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.

Detailed Description:

To evaluate the long-term antibody persistence, volunteers will be bled at Years 6, 7, 8, 9 and 10 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.

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 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects participating in this study should have participated in the primary study with combined hepatitis A/ hepatitis B vaccine.
  • Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood sampling visit of each year.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289744

Locations
Belgium
GSK Investigational Site
Wilrijk, Belgium, 2610
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00289744     History of Changes
Other Study ID Numbers: 100561 (Y6), 100562 (Year 7), 100563 (Year 8), 100564 (Year 9), 100565 (Year 10)
Study First Received: February 9, 2006
Results First Received: April 8, 2010
Last Updated: October 27, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Hepatitis A
Hepatitis B
TWINRIX™ ADULT

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 April 16, 2014