Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).

Phase 3

Completed

• Conditions: Hepatitis B
• Interventions: Biological: HBV-MPL vaccine 208129; Biological: Engerix™-B

• Registration Number: NCT00697216
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study evaluates the safety and immunogenicity of the candidate HBV-MPL vaccine administered to healthy adults aged from 15 to 40 years, according to a 0, 6- month vaccination schedule, with Engerix™-B as control administered at 0, 1, 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: 1997-03
• Primary Completion: 1999-03
• 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: 340

Inclusion Criteria

• Age: between 15 and 40 years old.
• Good physical condition as established by clinical examination and history taking at the time of entry.
• Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
• Written informed consent obtained from the subjects aged between 18 and 40 and from the parents/tutor when the subjects are aged between 15 and 17 years.

Exclusion Criteria

• Positive titres at screening for anti-HBs antibodies.
• Elevated serum liver enzymes.
• History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
• Any acute disease at the moment of entry.
• Chronic alcohol consumption.
• Hepatomegaly, right upper quadrant abdominal pain or tenderness.
• Any chronic drug treatment, including any treatment with immunosuppressive drugs, 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 participation in any other clinical trial.
• Previous vaccination with a hepatitis B vaccine.
• Previous vaccination with an MPL containing vaccine.
• Administration of immunoglobulins in the past 6 months and during the whole study period
• Simultaneous vaccination one week before and one week after each dose of the study vaccine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	HBV-MPL vaccine 208129	-
Group B	Engerix™-B	-

Primary Outcome Measures

Name	Time	Method
Anti-HBs antibody concentrations	Month 7

Secondary Outcome Measures

Name	Time	Method
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms	4-day follow-up period after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms	31-day follow-up after vaccination
Occurrence and relationship to vaccination of Serious Adverse Events (SAEs)	During the study period
Anti-HBs antibody concentrations	At months 1, 2, 6, 7 and 12

Trial Locations

Locations (1)

GSK Clinical Trials Call Center; 🇩🇰 Copenhagen, Denmark