Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00697840

Purpose

The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when administered at 0, 6 months

Condition	Intervention	Phase
Hepatitis B	Biological: Engerix™-B Biological: HBV-MPL 208129 Biological: Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation	Phase III

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines Sodium chloride Aluminum Recombinant hepatitis B vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Study to Assess the Safety, Immunogenicity and Reactogenicity of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Adjuvanted Recombinant Hepatitis B Vaccine, Recombinant Hepatitis B Vaccine New Formulation and Engerix™-B

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-HBs antibody concentrations [ Time Frame: At month 7 ]
Occurrence and intensity of solicited local and general symptoms [ Time Frame: 4-day follow-up after vaccination ]
Occurrence of unsolicited adverse events [ Time Frame: 30-days after vaccination ]
Incidence of serious adverse events [ Time Frame: Throughout the study period ]
Anti-Hbs antibody concentrations [ Time Frame: Months 1, 6 and 24 ]

Enrollment:	150
Study Start Date:	June 1995
Study Completion Date:	January 1996
Primary Completion Date:	January 1996 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental	Biological: HBV-MPL 208129 Intramuscular injection, 2 doses
Group B: Active Comparator	Biological: Engerix™-B Intramuscular injection, 2 doses
Group C: Experimental	Biological: Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation Intramuscular injection, 2 doses; experimental formulation

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:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Between 18 and 40 years old.
Written informed consent will have been obtained from the subjects.
Good physical condition as established by physical examination and history taking at the time of entry.
Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry

Exclusion Criteria:

Pregnancy or lactation.
Positive titres for anti HBs antibody.
Any vaccination against hepatitis B in the past.
Any previous administration of MPL.
Elevated serum liver enzymes.
History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
Axillary temperature > 37.5°C at the time of injection.
Any acute disease at the moment of entry.
Chronic alcohol consumption.
Any treatment with immunosuppressive or immunostimulant therapy.
Any chronic drug treatment, 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 administration of any other vaccine(s).
Administration of any immunoglobulin during the study period.
Simultaneous participation in any other clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697840

Locations

Austria
GSK Clinical Trials Call Center
Vienna, Austria

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Isabelle Harpigny )
Study ID Numbers:	208129/019
Study First Received:	June 12, 2008
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00697840
Health Authority:	Austria: Ethikkommission

Keywords provided by GlaxoSmithKline:

Hepatitis B
Engerix™-B
Recombinant hepatitis B vaccine
Adjuvant

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