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Completed

NCT Number: NCT00699231

Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs 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

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Clinical Trials Call Center

Brussels, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HBV-MPL vaccine 208129

Biological

IM injection

Engerix™-B

Biological

IM injection

Primary outcomes

  1. Occurrence and intensity of solicited local and general symptoms

    Time frame: 4-day follow-up period after each vaccination

  2. Occurrence of unsolicited adverse events

    Time frame: During the course of the study

  3. Occurrence of serious adverse events

    Time frame: During the course of the study

  4. Anti-HBs antibody concentrations

    Time frame: Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
1992
Primary completion
1992
Study completion
1992
First posted
Jun 17, 2008
Registry last updated
Jun 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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