Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL... | NCT00697775

NCT00697775

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	HBV-MPL Formulation A at months 0 and 6	Biological: HBV-MPL vaccine Formulation A
Group B	Experimental	HBV-MPL Formulation B at months 0 and 6	Biological: HBV-MPL vaccine Formulation B
Group C	Experimental	HBV-MPL Formulation A at month 0 and Engerix™-B at month 6	Biological: HBV-MPL vaccine Formulation A Biological: Engerix™-B
Group D	Active Comparator	Engerix™-B at months 0, 1, 6	Biological: Engerix™-B

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HBV-MPL vaccine Formulation A	Biological	Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection	Group A

Outcomes Module

Primary Outcomes

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

Measure	Description	Time Frame
Anti-HBs antibody concentrations		At months 1, 2, 6, and 7
Cell mediated immunity		At months 1, 6, and 7

Eligibility Module

Eligibility 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