Long-Term Follow-Up Studies at Year 6, 7, 8, 9, 10: 2 Formulations of Combined Hepatitis A/B Vaccine Compared in Subjects Aged 12-15 Years

Study Overview
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Brief Summary
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To evaluate the persistence of anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface antigen (anti-HBs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first dose of the study vaccine.

Detailed Description
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Open, randomized, long-term antibody persistence studies. Immune persistence was compared between subjects who received one of the two formulations of GlaxoSmithKline Biologicals' combined hepatitis A and hepatitis B vaccine according to a two-dose or three-dose schedule. These long-term follow-up studies involved taking blood samples at approximately 6, 7, 8, 9 and 10 years after the primary vaccination of combined hepatitis A and B vaccine, to assess antibody persistence and a retrospective safety follow-up. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Official Title
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Evaluate Persistence of Immune Response of GSK Biologicals' TWINRIX™ Vaccine Administered According to 0,6 Month Schedule Versus TWINRIX™ JUNIOR Administered According to 0,1,6 Month Schedule, in Subjects Aged 12-15 Years at Time of First Vaccine Dose

Conditions
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Hepatitis B, Hepatitis A

Intervention / Treatment
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* Biological: Twinrix™ Adult
* Biological: Twinrix™ Junior


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female volunteers vaccinated in study HAB-084. Written informed consent obtained from the subject before the blood sampling visit of each year. Exclusion Criteria: • none

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 15 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Twinrix Adult<br>Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study. | Biological: Twinrix™ Adult<br>* Intramuscular administration in the deltoid region (2 doses).<br>|
| Active Comparator: Group Twinrix Junior<br>Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study. | Biological: Twinrix™ Junior<br>* Intramuscular administration in the deltoid region (3 doses).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value | Anti-HAV antibody concentration cut-off value assessed was ≥ 15 milli-International Units per milliliter (mIU/mL). | Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination | 
| Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | Anti-HBs antibody concentration cut-off value assessed was ≥ 3.3 mIU/mL. | Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination | 
| Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling) | 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. | From Year 6 through to Year 10 | 

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