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
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: 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 August 28, 2014