Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00697125

Purpose

The purpose of this study is to evaluate the immunogenicity and reactogenicity of various formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult volunteers following the 0, 1, 6 months schedule

Condition	Intervention	Phase
Hepatitis B	Biological: Engerix™-B Biological: HBV-MPL vaccine (208129) Biological: Hepatitis B vaccine, experimental formulation	Phase II

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, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccine With Different Adjuvants in Healthy Adult Volunteers

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence and intensity of solicited local and general symptoms [ Time Frame: 8 days follow-up after vaccination ]

Secondary Outcome Measures:

Anti-HBs antibody concentrations [ Time Frame: Months 0, 1, 3, 6, 7, 8 and 12 ]
Occurrence, intensity of unsolicited adverse events [ Time Frame: 30-day follow-up after vaccination ]
Occurrence of serious adverse events [ Time Frame: During the study period up to 30 days after last vaccination ]

Enrollment:	60
Study Start Date:	June 1993
Study Completion Date:	July 1994
Primary Completion Date:	July 1994 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Active Comparator	Biological: Engerix™-B Intramuscular injection, 3 doses
Group B: Experimental	Biological: Hepatitis B vaccine, experimental formulation Intramuscular injection, 3 doses
Group C: Experimental	Biological: HBV-MPL vaccine (208129)

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.
Serological signs of HBV infection
Elevated serum liver enzymes
Any vaccination against hepatitis B in the past.
Any previous administration of MPL.
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.
Administration of any other vaccine(s) or 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: NCT00697125

Locations

Belgium
GSK Clinical Trials Call Center
Gent, Belgium

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Isabelle Harpigny )
Study ID Numbers:	208129/005
Study First Received:	June 11, 2008
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00697125
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by GlaxoSmithKline:

Hepatitis B
Engerix™-B
Recombinant 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