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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Hepatitis B

Treatments: Biological: Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation; Biological: Engerix™-B; Biological: HBV-MPL 208129

Study type: Interventional

Funder types: Industry

Identifiers

NCT00697840

208129/019

Details and patient eligibility

About

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

Full description

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

Enrollment: 150 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups

Group A

Experimental group

Treatment:

Biological: HBV-MPL 208129

Group B

Active Comparator group

Treatment:

Biological: Engerix™-B

Group C

Experimental group

Treatment:

Biological: Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation