Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B

Study Overview
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Brief Summary
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The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when administered at 0, 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 to Assess the Safety, Immunogenicity and Reactogenicity of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Adjuvanted Recombinant Hepatitis B Vaccine, Recombinant Hepatitis B Vaccine New Formulation and Engerix™-B

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Engerix™-B
* Biological: HBV-MPL 208129
* Biological: Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation


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 HBs antibody. 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: HBV-MPL 208129<br>* Intramuscular injection, 2 doses<br>|
| Active Comparator: Group B<br> | Biological: Engerix™-B<br>* Intramuscular injection, 2 doses<br>|
| Experimental: Group C<br> | Biological: Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation<br>* Intramuscular injection, 2 doses; experimental formulation<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 | 
| Occurrence and intensity of solicited local and general symptoms |  | 4-day follow-up after vaccination | 
| Occurrence of unsolicited adverse events |  | 30-days after vaccination | 
| Incidence of serious adverse events |  | Throughout the study period | 
| Anti-Hbs antibody concentrations |  | Months 1, 6 and 24 | 

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