Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B

Study Overview
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Brief Summary
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The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary

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 to Compare the Safety, Immunogenicity and Reactogenicity of Different Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: MPL-Adjuvanted recombinant hepatitis B vaccine
* Biological: Engerix™-B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18 and 40 years old. Written informed consent will have been obtained from the subjects. Good physical condition as established by physical examination and history taking at the time of entry. Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry Exclusion Criteria: Pregnancy or lactation. Positive titres for anti hepatitis B antibodies Any vaccination against hepatitis B in the past. Any previous administration of MPL. Elevated serum liver enzymes. History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. Axillary temperature > 37.5°C at the time of injection. Any acute disease at the moment of entry. Chronic alcohol consumption. Any treatment with immunosuppressive or immunostimulant therapy. Any chronic drug treatment, 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 administration of any other vaccine(s). Administration of any immunoglobulin during the study period. Simultaneous participation in any other clinical trial

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Biological: MPL-Adjuvanted recombinant hepatitis B vaccine<br>* Intramuscular injection, 2 or 3 doses, 2 different formulations<br>|
| Active Comparator: Group B<br> | Biological: Engerix™-B<br>* Intramuscular injection, 2 or 3 doses<br>|
| Experimental: Group C<br> | Biological: MPL-Adjuvanted recombinant hepatitis B vaccine<br>* Intramuscular injection, 2 or 3 doses, 2 different formulations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs antibody concentrations |  | At M3 and M13 | 
| Occurrence of local and general solicited symptoms |  | 4-day follow-up after vaccination | 
| Occurrence of unsolicited symptoms |  | 30-day follow-up after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAEs |  | Throughout the study up to 30 days after last vaccination | 
| Anti-HBs antibody concentrations |  | Months 2, 3, 6, 9, 12, 13 | 

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