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

June 11, 2008 updated by: GlaxoSmithKline

Study Comparing the Immunogenicity and Reactogenicity of GSK Biologicals' HBV-MPL Vaccine Injected According to a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in a Healthy Adult Population (15-40 Years)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

340

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • GSK Clinical Trials Call Center
  • Denmark
      • Copenhagen, Denmark
        • GSK Clinical Trials Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection
Active Comparator: Group B
Biological: Engerix™-B
3-dose intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-HBs antibody concentrations
Time Frame: Month 7
Month 7

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1997

Primary Completion (Actual)

March 1, 1999

Study Registration Dates

First Submitted

June 11, 2008

First Submitted That Met QC Criteria

June 11, 2008

First Posted (Estimate)

June 13, 2008

Study Record Updates

Last Update Posted (Estimate)

June 13, 2008

Last Update Submitted That Met QC Criteria

June 11, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 208129/027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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