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

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00383591

Purpose

Persistence of anti-HBs antibodies at Month 24, 30 and 36 in subjects who had completed primary vaccination was evaluated. The anamnestic response to a booster dose was evaluated in subjects with anti-HBs antibody titres < 10 mIU/ml at previous timepoint. The study also evaluated the effect of a booster dose of the vaccine (Month 42) after primary vaccination.

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Clinical Trial Comparing the Persistence of GSK Biologicals New Adjuvanted Hepatitis B Vaccine to a Double Dose of Engerix™-B at Months 24, 30, 36, in Pre-Haemodialysis/Haemodialysis Patients (≥15 Years of Age)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-HBs seroprotection
Response to booster

Secondary Outcome Measures:

Solicited, unsolicited symptoms and serious adverse events

Estimated Enrollment:	120
Study Start Date:	March 2002

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects were to have completed primary vaccination course. 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.
If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she was to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.

Exclusion Criteria:

Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
Pregnant or lactating female.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383591

Locations

Czech Republic
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
Malaysia
GSK Investigational Site
Bandar Tun Razak, Cheras, Malaysia, 56000
Spain
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Malaga, Spain, 29010
GSK Investigational Site
Barcelona, Spain, 08036

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	208129/047
Study First Received:	October 2, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00383591
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:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 14, 2009