Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients

June 16, 2008 updated by: GlaxoSmithKline

Study to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine Versus Engerix™-B, in Haemodialysis Patients

This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis B

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)

30

Phase

  • Phase 1

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dialysis patients
  • A medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study.
  • Age: from 18 years onwards
  • Seronegative for anti- hepatitis antibodies

Exclusion Criteria:

  • History of persistent hepatic, cardiac or respiratory disease
  • Any acute disease at the moment of entry into the study
  • Chronic alcohol consumption
  • Hepatomegaly, right upper quadrant pain or tenderness
  • Any treatment with coticosteroids or immunomodulating drugs
  • Known hypersensitivity to any component of the vaccine
  • Simultaneous participation in any other clinical trial

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A1
Non-responders to vaccination after at least 7 previous injections
Biological: Engerix™-B
IM injection
Experimental: Group A2
Non-responders to vaccination after at least 7 previous injections
Biological: HBV-MPL vaccine 208129
IM injection
Active Comparator: Group B1
Vaccine-responders requiring a booster dose
Biological: Engerix™-B
IM injection
Experimental: Group B2
Vaccine-responders requiring a booster dose
Biological: HBV-MPL vaccine 208129
IM injection
Active Comparator: Group C1
Volunteers participating in the hospital's vaccination program
Biological: Engerix™-B
IM injection
Experimental: Group C2
Volunteers participating in the hospital's vaccination program
Biological: HBV-MPL vaccine 208129
IM injection
Active Comparator: Group D1
Unvaccinated haemodialysis patients
Biological: Engerix™-B
IM injection
Experimental: Group D2
Unvaccinated haemodialysis patients
Biological: HBV-MPL vaccine 208129
IM injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence and intensity of solicited local and general symptoms
Time Frame: 4-day follow-up period after each vaccination
4-day follow-up period after each vaccination
Occurrence of unsolicited adverse events
Time Frame: During the course of the study
During the course of the study
Occurrence of serious adverse events
Time Frame: During the course of the study
During the course of the study
Anti-HBs antibody concentrations
Time Frame: Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation
Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation

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

February 1, 1992

Primary Completion (Actual)

December 1, 1992

Study Completion (Actual)

December 1, 1992

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 16, 2008

First Posted (Estimate)

June 17, 2008

Study Record Updates

Last Update Posted (Estimate)

June 17, 2008

Last Update Submitted That Met QC Criteria

June 16, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 208129/002

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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3
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