Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs). - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00697216

Purpose

This study evaluates the safety and immunogenicity of the candidate HBV-MPL vaccine administered to healthy adults aged from 15 to 40 years, according to a 0, 6- month vaccination schedule, with Engerix™-B as control administered at 0, 1, 6 months.

Condition	Intervention	Phase
Hepatitis B	Biological: HBV-MPL vaccine 208129 Biological: Engerix™-B	Phase III

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines Recombinant hepatitis B vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study Comparing the Immunogenicity and Reactogenicity of GSK Biologicals' HBV-MPL Vaccine Injected According to a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in a Healthy Adult Population (15-40 Years)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Anti-HBs antibody concentrations [ Time Frame: At months 1, 2, 6, 7 and 12 ]
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms [ Time Frame: 4-day follow-up period after vaccination ]
Occurrence, intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: 31-day follow-up after vaccination ]
Occurrence and relationship to vaccination of Serious Adverse Events (SAEs) [ Time Frame: During the study period ]

Enrollment:	340
Study Start Date:	March 1997
Primary Completion Date:	March 1999 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental	Biological: HBV-MPL vaccine 208129 2-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:	15 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age: between 15 and 40 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 aged between 18 and 40 and from the parents/tutor when the subjects are aged between 15 and 17 years.

Exclusion Criteria:

Positive titres at screening for anti-HBs 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 hepatitis B vaccine.
Previous vaccination with an MPL containing vaccine.
Administration of immunoglobulins in the past 6 months and during the whole study period
Simultaneous 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: NCT00697216

Locations

Belgium
GSK Clinical Trials Call Center
Brussels, Belgium
Denmark
GSK Clinical Trials Call Center
Copenhagen, Denmark

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Isabelle Harpigny )
Study ID Numbers:	208129/027
Study First Received:	June 11, 2008
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00697216
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by GlaxoSmithKline:

Hepatitis B
Recombinant hepatitis B vaccine
Adjuvanted hepatitis B vaccine

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections
Healthy

Additional relevant MeSH terms:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 15, 2009