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

NCT ID: NCT00697242

Last Updated: 2008-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

362 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-01-31

Study Completion Date

1995-11-30

Brief Summary

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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

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

Conditions

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Hepatitis B

Keywords

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Hepatitis B Engerix™-B Recombinant Hepatitis B vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group A

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

Intramuscular injection, 3 doses

Group B

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

Intramuscular injection, 3 doses

Group C

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

Intramuscular injection, 3 doses

Group D

Group Type ACTIVE_COMPARATOR

Engerix™-B

Intervention Type BIOLOGICAL

Intramuscular injection, 3 doses

Group E

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

Intramuscular injection, 3 doses

Interventions

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Engerix™-B

Intramuscular injection, 3 doses

Intervention Type BIOLOGICAL

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

Intramuscular injection, 3 doses

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Clinical Trials Call Center

Vienna, , Austria

Site Status

GSK Clinical Trials Call Center

Ghent, , Belgium

Site Status

GSK Clinical Trials Call Center

Hvidovre, , Denmark

Site Status

GSK Clinical Trials Call Center

Reykjavik, , Iceland

Site Status

Countries

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Austria Belgium Denmark Iceland

Other Identifiers

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208129/009

Identifier Type: -

Identifier Source: org_study_id