Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults

Study Overview
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Brief Summary
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This study is conducted to compare the immunogenicity, reactogenicity and safety of Engerix™-B and HBV-MPL vaccine against hepatitis B infection in an elderly population

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 Immunogenicity, Reactogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine With That of Engerix™-B When Both Are Injected According to 3 Dose Schedule (0, 1, 6 Months) in an Adult Population Aged Between 50 and 70 Years

Conditions
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Hepatitis B

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 50 to 70 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 Exclusion Criteria: Positive at screening for anti-HBV 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 recombinant hepatitis B vaccine. Previous vaccination with an MPL containing vaccine. Administration of immunoglobulins in the past 6 months and during the whole study period Vaccination one week before and one week after each dose of the study vaccine

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Biological: HBV-MPL vaccine<br>* 3-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 |  | At Month 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs antibody concentrations |  | At Months 1, 2, 6, 7 and 12 | 
| Occurrence and intensity of solicited local symptoms |  | 4-day follow-up after vaccination | 
| Occurrence and intensity and relationship to vaccination of solicited general symptoms |  | 4-day follow-up after vaccination | 
| Occurrence and intensity of any symptoms (solicited/ unsolicited). |  | 4-day follow-up after vaccination | 
| Occurrence, intensity and causal relationship of unsolicited symptoms |  | Within 30 days after vaccination | 
| Serious adverse events |  | Throughout study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adjuvanted hepatitis B vaccine, hepatitis B, Engerix™-B