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

Phase 3

Completed

• Conditions: Hepatitis B

• Registration Number: NCT00697840
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

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: 1995-06
• Primary Completion: 1996-01
• Study Completion: 1996-01
• Status Verified: 2008-06
• Study First Submitted: 2008-06-12
• Study First Submitted QC: 2008-06-13
• Last Update Submitted: 2008-06-13
• Study First Posted: 2008-06-16
• Last Update Posted: 2008-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anti-HBs antibody concentrations	At month 7
Occurrence and intensity of solicited local and general symptoms	4-day follow-up after vaccination
Occurrence of unsolicited adverse events	30-days after vaccination
Incidence of serious adverse events	Throughout the study period
Anti-Hbs antibody concentrations	Months 1, 6 and 24

Trial Locations

Locations (1)

GSK Clinical Trials Call Center; 🇦🇹 Vienna, Austria