Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).

Study Overview
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Brief Summary
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This study evaluates the safety and immunogenicity of the candidate HBV-MPL vaccine administered to healthy adults aged from 15 to 40 years, according to a 0, 6- month vaccination schedule, with Engerix™-B as control administered at 0, 1, 6 months.

Detailed Description
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At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Official Title
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Study Comparing the Immunogenicity and Reactogenicity of GSK Biologicals' HBV-MPL Vaccine Injected According to a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in a Healthy Adult Population (15-40 Years)

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: HBV-MPL vaccine 208129
* Biological: Engerix™-B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: between 15 and 40 years old. Good physical condition as established by clinical examination and history taking at the time of entry. Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period. Written informed consent obtained from the subjects aged between 18 and 40 and from the parents/tutor when the subjects are aged between 15 and 17 years. Exclusion Criteria: Positive titres at screening for anti-HBs antibodies. Elevated serum liver enzymes. History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. Any acute disease at the moment of entry. Chronic alcohol consumption. Hepatomegaly, right upper quadrant abdominal pain or tenderness. Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study. History of allergic disease likely to be stimulated by any component of the vaccine. Simultaneous participation in any other clinical trial. Previous vaccination with a hepatitis B vaccine. Previous vaccination with an MPL containing vaccine. Administration of immunoglobulins in the past 6 months and during the whole study period Simultaneous vaccination one week before and one week after each dose of the study vaccine

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 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 |
| --- | --- |
| Experimental: Group A<br> | Biological: HBV-MPL vaccine 208129<br>* 2-dose intramuscular injection<br>|
| Active Comparator: Group B<br> | Biological: Engerix™-B<br>* 3-dose intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs antibody concentrations |  | Month 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs antibody concentrations |  | At months 1, 2, 6, 7 and 12 | 
| Occurrence, intensity and relationship to vaccination of solicited local and general symptoms |  | 4-day follow-up period after vaccination | 
| Occurrence, intensity and relationship to vaccination of unsolicited symptoms |  | 31-day follow-up after vaccination | 
| Occurrence and relationship to vaccination of Serious Adverse Events (SAEs) |  | During the study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B, Recombinant hepatitis B vaccine, Adjuvanted hepatitis B vaccine