Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Hepatitis B

Treatments: Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL; Biological: Engerix™-B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00697242

208129/009

Details and patient eligibility

About

In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B vaccines with and without MPL will be evaluated in older healthy subjects

Full description

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

Enrollment: 362 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female subjects between 50 and 70 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

Exclusion criteria

• Positive titres for anti hepatitis antibodies
• Any vaccination against hepatitis B in the past.
• Any previous administration of MPL
• Elevated serum liver enzymes at two subsequent determinations 14 days apart.
• 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.
• Administration of any other vaccine(s) or 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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362 participants in 5 patient groups

Group A

Experimental group

Treatment:

Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL

Group B

Experimental group

Treatment:

Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL

Group C

Experimental group

Treatment:

Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL

Group D

Active Comparator group

Treatment:

Biological: Engerix™-B

Group E

Experimental group

Treatment:

Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL