Comparison of Monodose and Multidose Presentations of GSK Biologicals' Hepatitis B Vaccine in Terms of Immune Response

Study Overview
=================
Brief Summary
-----------------
GSK Biologicals' currently licensed multidose hepatitis B vaccine will be compared to the currently licensed monodose hepatitis B vaccine in a population with well documented hepatitis B immunological response to the vaccine (Belgium).

Detailed Description
-----------------
Randomized study with two groups. One group will receive GSK's multidose hepatitis B vaccine and the other group will receive GSK's monodose hepatitis B vaccine

Official Title
-----------------
Demonstrate the Non-inferiority of Immunogenicity Elicited by GSK Biologicals' Hepatitis B Vaccine, Multidose Engerix™-B to That of Monodose Engerix™-B When Administered According to 0,1,6 Mths Schedule in Healthy Adults Aged ≥ 18 Yrs

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Biological: Hepatitis B vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: A male or female >= 18 years of age Written informed consent obtained from the subject. Free of obvious health problems as established by medical history and clinical examination before entering into the study. If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Exclusion criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine. Previous vaccination against hepatitis B History of hepatitis B infection Known exposure to hepatitis B within the previous 6 weeks Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. A family history of congenital or hereditary immunodeficiency. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature < 37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F). Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions during the study period.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Hepatitis B vaccine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of antibody concentrations to hepatitis B antigen at Month 7. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of antibody concentrations to hepatitis antigen at Months 1,2and6. Occurrence of solicited local symptoms and solicited general symptoms during the 4-day f/u period after vaccination. Occurrence, intensity and relationship to vaccination |  |  |