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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 13, 2008

Last Updated Date

June 16, 2008

Start Date ^†

February 1992

Current Primary Outcome Measures ^†

Occurrence and intensity of solicited local and general symptoms [ Time Frame: 4-day follow-up period after each vaccination ]
Occurrence of unsolicited adverse events [ Time Frame: During the course of the study ]
Occurrence of serious adverse events [ Time Frame: 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00699231 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official 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

Brief Summary

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

Detailed Description

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

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^†

Hepatitis B

Intervention ^†

Biological: HBV-MPL vaccine 208129
Biological: Engerix™-B

Study Arms / Comparison Groups

Active Comparator: Non-responders to vaccination after at least 7 previous injections
Experimental: Non-responders to vaccination after at least 7 previous injections
Active Comparator: Vaccine-responders requiring a booster dose
Experimental: Vaccine-responders requiring a booster dose
Active Comparator: Volunteers participating in the hospital's vaccination program
Experimental: Volunteers participating in the hospital's vaccination program
Active Comparator: Unvaccinated haemodialysis patients
Experimental: Unvaccinated haemodialysis patients

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

December 1992

Primary Completion Date

December 1992 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Belgium

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00699231

Responsible Party

Isabelle Harpigny, GSK

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.