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

Study Overview
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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 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.

Detailed Description
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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.

Official Title
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Long-Term Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Children

Conditions
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Hepatitis B, Hepatitis A

Intervention / Treatment
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* Biological: TWINRIX™ ADULT
* Biological: Engerix TM


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Twinrix Group<br>Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix in the primary study (208127/076) | Biological: TWINRIX™ ADULT<br>* 2 doses IM injection in primary study<br>|
| Experimental: Engerix-B Additional Dose (Adult)<br>Subjects aged 16 years and above who received an additional dose of EngerixTM-B (adult dose). | Biological: Engerix TM<br>* 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.<br>|
| Experimental: Engerix-B Additional Dose (Pediatric)<br>Subjects under the age of 16 years who received an additional dose of EngerixTM-B (pediatric dose). | Biological: Engerix TM<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration |  | Years 6, 7, 8, 9, and 10. | 
| Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration |  | At Year 6, 7, 8, 9 and 10 | 
| Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration |  | Before and 1 month after the additional dose administration | 
| Number of Subjects With Immune Response to the Additional Dose of Engerix™-B | 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. | One month after the additional dose administration | 
| 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 | 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. | At Year 6, 7, 8, 9 and 10 | 
| Number of Subjects Reporting Solicited Local and General Symptoms | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache. | During the 4-day follow-up period after additional dose | 
| Number of Subjects Reporting Unsolicited Adverse Events | 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. | During the 30-day follow-up period after additional dose | 
| Number of Subjects Reporting Serious Adverse Events (SAEs) | 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. | During the 30-day follow-up period after additional dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis A, Hepatitis B, TWINRIX™ ADULT