Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years

October 2, 2006 updated by: GlaxoSmithKline

To Compare the Immunogenicity & Safety of GSK Biologicals New Adjuvanted Hepatitis B Vaccine to a Double Dose of Engerix™-B, in Pre-Haemodialysis/Haemodialysis Patients (≥15 Years of Age)

Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

141

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

  • Czech Republic
    • Králové
      • Hradec, Králové, Czech Republic
        • GSK Clinical Trials Call Center
  • Malaysia
      • Kuala Lumpur, Malaysia
        • GSK Clinical Trials Call Center
  • Spain
      • Malaga, Spain
        • 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 and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A male or female > = 15 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject/ from the parents or guardians of the subject.
  • Seronegative for anti-HBs antibodies, anti-HBc antibodies & Hepatitis B Surface antigen (HBsAg).
  • If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.
  • Pre-haemodialysis patient* or a patient on haemodialysis.

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
  • Previous vaccination against hepatitis B.
  • History of hepatitis B infection.
  • Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female
  • Clinically abnormal ALT/AST values (> 3 times normal values)

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Anti-HBs seroprotection rates at Month 12.

Secondary Outcome Measures

Outcome Measure
Solicited symptoms, unsolicited symptoms and serious adverse events

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

December 1, 1999

Study Registration Dates

First Submitted

October 2, 2006

First Submitted That Met QC Criteria

October 2, 2006

First Posted (Estimate)

October 3, 2006

Study Record Updates

Last Update Posted (Estimate)

October 3, 2006

Last Update Submitted That Met QC Criteria

October 2, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 208129/042

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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