Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00696891

Purpose

This study is conducted to compare the immunogenicity, reactogenicity and safety of Engerix™-B and HBV-MPL vaccine against hepatitis B infection in an elderly population

Condition	Intervention	Phase
Hepatitis B	Biological: HBV-MPL vaccine Biological: Engerix™-B	Phase III

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Official Title:	Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine With That of Engerix™-B When Both Are Injected According to 3 Dose Schedule (0, 1, 6 Months) in an Adult Population Aged Between 50 and 70 Years

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-HBs antibody concentrations [ Time Frame: At Month 7 ]

Secondary Outcome Measures:

Anti-HBs antibody concentrations [ Time Frame: At Months 1, 2, 6, 7 and 12 ]
Occurrence and intensity of solicited local symptoms [ Time Frame: 4-day follow-up after vaccination ]
Occurrence and intensity and relationship to vaccination of solicited general symptoms [ Time Frame: 4-day follow-up after vaccination ]
Occurrence and intensity of any symptoms (solicited/ unsolicited). [ Time Frame: 4-day follow-up after vaccination ]
Occurrence, intensity and causal relationship of unsolicited symptoms [ Time Frame: Within 30 days after vaccination ]
Serious adverse events [ Time Frame: Throughout study period ]

Enrollment:	380
Study Start Date:	June 1997
Primary Completion Date:	May 1999 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental	Biological: HBV-MPL vaccine 3-dose intramuscular injection
Group B: Active Comparator	Biological: Engerix™-B 3-dose intramuscular injection

Detailed Description:

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

Eligibility

Ages Eligible for Study:	50 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age: 50 to 70 years old.
Good physical condition as established by clinical examination and history taking at the time of entry.
Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
Written informed consent obtained from the subjects

Exclusion Criteria:

Positive at screening for anti-HBV antibodies.
Elevated serum liver enzymes
History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
Any acute disease at the moment of entry.
Chronic alcohol consumption.
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.
History of allergic disease likely to be stimulated by any component of the vaccine.
Simultaneous participation in any other clinical trial.
Previous vaccination with a recombinant hepatitis B vaccine.
Previous vaccination with an MPL containing vaccine.
Administration of immunoglobulins in the past 6 months and during the whole study period
Vaccination one week before and one week after each dose of the study vaccine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696891

Locations

Belgium
GSK Clinical Trials Call Center
Wilrijk, Belgium
Canada
GSK Clinical Trials Call Center
Toronto, Canada
Sweden
GSK Clinical Trials Call Center
Göteborg, Sweden

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Isabelle Harpigny )
Study ID Numbers:	208129/022
Study First Received:	June 11, 2008
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00696891
Health Authority:	Sweden: Medical Products Agency

Keywords provided by GlaxoSmithKline:

Adjuvanted hepatitis B vaccine, hepatitis B, Engerix™-B

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 15, 2009