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

Phase 3

Completed

• Conditions: Hepatitis B
• Interventions: Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL; Biological: Engerix™-B

• Registration Number: NCT00697242
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

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

Study Timeline

• Study Start: 1994-01
• Primary Completion: 1995-11
• Study Completion: 1995-11
• Status Verified: 2008-06
• Study First Submitted: 2008-06-11
• Study First Submitted QC: 2008-06-11
• Last Update Submitted: 2008-06-11
• Study First Posted: 2008-06-13
• Last Update Posted: 2008-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group E	Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL	-
Group A	Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL	-
Group B	Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL	-
Group C	Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL	-
Group D	Engerix™-B	-

Primary Outcome Measures

Name	Time	Method
Anti-hepatitis B surface antigen (HBs) antibody concentrations	At M2 and M7

Secondary Outcome Measures

Name	Time	Method
Anti-pre-S1 antibody concentrations	Screening, Months 1, 2, 3, 6, 7, 8 and 12, depending on group allocation
Anti-HBs antibody concentrations	Screening, Months 1, 2, 3, 6, 7, 8 and 12
Occurrence and intensity of local and general solicited symptoms	4-day after vaccination
Cell mediated immunity	Month 0, Month 2 and month 7
Occurrence of unsolicited adverse events	30 days after vaccination
Occurrence of serious adverse events	During the study period and 30 days after last vaccine dose

Trial Locations

Locations (1)

GSK Clinical Trials Call Center; 🇮🇸 Reykjavik, Iceland