Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00697775

Purpose

In this study the safety and immunogenicity of 2 different formulations of the candidate HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to that of Engerix™-B in healthy adolescents aged 11 to 15

Condition	Intervention	Phase
Hepatitis B	Biological: HBV-MPL vaccine Formulation A Biological: HBV-MPL vaccine Formulation B Biological: Engerix™-B	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, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study to Assess the Feasibility of GSK Bio's Candidate HBV / MPL Vaccines Following Different Schedules and Formulations and to Compare Their Safety and Immunogenicity to That of Engerix™-B in Healthy Adolescents Aged 11 to 15

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of Serious adverse experiences (SAE) [ Time Frame: During the study period ]
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms [ Time Frame: During the 8-day follow-up period after vaccination ]
Occurrence, intensity and causal relationship of unsolicited adverse events [ Time Frame: 31-day follow-up period after vaccination ]

Secondary Outcome Measures:

Anti-HBs antibody concentrations [ Time Frame: At months 1, 2, 6, and 7 ]
Cell mediated immunity [ Time Frame: At months 1, 6, and 7 ]

Enrollment:	200
Study Start Date:	March 1998
Primary Completion Date:	May 1999 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental HBV-MPL Formulation A at months 0 and 6	Biological: HBV-MPL vaccine Formulation A Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection
Group B: Experimental HBV-MPL Formulation B at months 0 and 6	Biological: HBV-MPL vaccine Formulation B 2-dose intramuscular injection
Group C: Experimental HBV-MPL Formulation A at month 0 and Engerix™-B at month 6	Biological: HBV-MPL vaccine Formulation A Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection Biological: Engerix™-B Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection
Group D: Active Comparator Engerix™-B at months 0, 1, 6	Biological: Engerix™-B Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) 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:	11 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age: between 11 and 15 years at the time of the first vaccination.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Written informed consent obtained from the parents or guardians of the subject and from the subject himself/herself in all subjects 15 years of age.
If the subject is female, she must be of non-childbearing potential, if of childbearing potential, she must be abstinent or have used an adequate contraceptive for one month prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series

Exclusion Criteria:

Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
Planned administration of a vaccine not foreseen by the study protocol during the period starting from one week before each dose of vaccine and ending 30 days after.
Previous vaccination against hepatitis B virus.
Previous vaccination with vaccine containing MPL.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Acute disease at the time of enrollment.
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Axillary temperature of ≥ 37.5° C.
Administration of immunoglobulin and / or any blood product within the six months preceding the first dose of study vaccine or planned administration during the study period.
Pregnant or lactating female.
History of chronic disease deemed by the investigator to be relevant.
Positive for anti-HBV antibodies at screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697775

Locations

Germany
GSK Clinical Trials Call Center
Mainz, Germany

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Isabelle Harpigny )
Study ID Numbers:	208129/028
Study First Received:	June 12, 2008
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00697775
Health Authority:	Germany: Ministry of Health

Keywords provided by GlaxoSmithKline:

Hepatitis 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
Healthy

Additional relevant MeSH terms:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 15, 2009