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

This study has been completed.

First Received: October 2, 2006 No Changes Posted

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00383383

Purpose

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

Condition	Intervention	Phase
Hepatitis B	Biological: Hepatitis B adjuvanted vaccine Biological: Engerix-B	Phase III

MedlinePlus related topics: Dialysis Hepatitis Hepatitis B Kidney Failure

Drug Information available for: Hepatitis B Vaccines

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	141
Study Start Date:	December 1999

Eligibility

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383383

Locations

Czech Republic, Králové
GSK Clinical Trials Call Center
Hradec, Králové, Czech Republic
Malaysia
GSK Clinical Trials Call Center
Kuala Lumpur, Malaysia
Spain
GSK Clinical Trials Call Center
Malaga, Spain

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Study ID Numbers:	208129/042
Study First Received:	October 2, 2006
Last Updated:	October 2, 2006
ClinicalTrials.gov Identifier:	NCT00383383 History of Changes
Health Authority:	Czech Republic: State Institute for Drug Control

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009