Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs

Study Overview
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Brief Summary
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To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course. Subjects were aged 11 to 15 years at the time of the primary vaccination course. At the time of enrollment in the present long-term follow-up study subjects were aged 13 to 18 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description
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All subjects who participated in the primary study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up at Month 42 were contacted by the investigators. No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Official Title
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Long-term Study of Immune Response Persistence of GSK Biologicals' 2-dose Thiomersal-free Engerix™-B and 3-dose Preservative-free Engerix™-B Vaccines in Subjects Aged 11-15 Yrs

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Engerix™-B (thiomersal-free) 20µg
* Biological: 10 μg Engerix™-B (preservative-free)
* Biological: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects have participated in primary study HBV-280 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: 13 Years
Maximum Age: 20 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2-Dose Engerix<br>subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month. | Biological: Engerix™-B (thiomersal-free) 20µg<br>* In the primary study: 2 deep intramuscular injections (Months 0, & 6)<br>Biological: placebo<br>* In the primary study: 1 deep intramuscular injection (month 1)<br>|
| Active Comparator: 3-Dose Engerix<br>subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively. | Biological: 10 μg Engerix™-B (preservative-free)<br>* In the primary study: 3 deep intramuscular injections (months 0, 1 & 6)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody. | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. | At Month 7 | 
| Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody. | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. | At Month 30, Month 42, Month 54 and Month 66 | 
| Antibody Titers Against Hepatitis-B Virus. | Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs. | At Month 30, Month 42, Month 54 and Month 66 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody Titers Against Hepatitis-B Virus. | Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs. | At Months 1, 2, 6 and 7 | 
| Number of Subjects Seroprotected for Anti-HBs Antibody. | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. | At Months 1, 2 and 6 | 
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | During the 4-day (Day 0-3) follow-up period after each vaccination and overall | 
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, and fever. Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Gastrointestinal symptoms included nausea, vomiting, diarrhea and abdominal pain. Grade 3 fever was defined as fever (axillary temperature) > 38.5°C. Grade 3 symptoms were defined as symptoms which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination. | During the 4-day (Day 0-3) follow-up period after each vaccination and overall | 
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE). | An unsolicited AE covers 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. | During the 31-day (Day 0-30) follow-up period after each vaccination and overall | 
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. | During the entire study period (Month 0 to Month 66) | 
| Number of Subjects With Serious Adverse Events (SAEs). | erious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. | At Month 30, Month 42, Month 54 & Month 66 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persistence, Hepatitis B vaccine