Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y

Study Overview
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Brief Summary
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This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL vaccine and to compare their safety and immunogenicity with that of Engerix™-B.

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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Safety and Immunogenicity of 3 Lots of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine, Administered According to a 2 Dose Schedule, and Engerix™-B Administered According to a 3 Dose Schedule to Healthy Volunteers ≥ 15 Years of Age

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: A male or female aged ≥ 15 years at the time of the first vaccination. In Centre 103 (Germany) and Centre 1 (Netherlands), only subjects ≥ 18 years will be enrolled. Free of obvious health problems as established by medical history and clinical examination before entering into the study. Written informed consent obtained from the subject and/or from the parent or guardian of the subject. If the subject was a female, she was of non-childbearing potential, if of childbearing potential, she was abstinent or used adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination Exclusion Criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine (s) during the study period or within 30 days preceding the first dose of study vaccine. Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after. Previous vaccination against hepatitis B. History of non-response to previous hepatitis B vaccination. Known exposure to hepatitis B within the past 6 weeks. History of hepatitis B infection. Confirmed 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. Acute disease at the time of enrollment. Hepatomegaly, right upper quadrant abdominal pain or tenderness. Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period. Pregnant or lactating female

Ages Eligible for Study
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Minimum Age: 15 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 |
| --- | --- |
| Active Comparator: Group A<br>Three doses according to 0, 1, 6-month schedule | Biological: Engerix™-B<br>* 3-dose intramuscular injection<br>|
| Experimental: Group B<br>Two doses according to 0, 6-month schedule, with a placebo injection at Month 1 | Biological: HBV-MPL vaccine 208129<br>* 2-dose intramuscular injection 3 different vaccine lots<br>|
| Experimental: Group C<br>Two doses according to 0, 6-month schedule, with a placebo injection at Month 1 | Biological: HBV-MPL vaccine 208129<br>* 2-dose intramuscular injection 3 different vaccine lots<br>|
| Experimental: Group D<br>Two doses according to 0, 6-month schedule, with a placebo injection at Month 1 | Biological: HBV-MPL vaccine 208129<br>* 2-dose intramuscular injection 3 different vaccine lots<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms |  | Full course of vaccination | 
| Incidence of serious adverse events |  | Study period | 
| Anti-HBs antibody concentrations |  | At Month 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence and intensity of solicited local signs and symptoms |  | 4-day after vaccination | 
| Occurrence, intensity and relationship to vaccination of solicited general signs and symptoms |  | 4-day after vaccination | 
| Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms |  | 30 days after vaccination | 
| Occurrence and relationship to vaccination of SAEs |  | During the study period | 
| Anti-HBs antibody concentrations |  | At Months 1, 2, 6 and 7 | 

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