Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents
NCT ID: NCT00697775
Last Updated: 2008-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
1998-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group A
HBV-MPL Formulation A at months 0 and 6
HBV-MPL vaccine Formulation A
Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection
Group B
HBV-MPL Formulation B at months 0 and 6
HBV-MPL vaccine Formulation B
2-dose intramuscular injection
Group C
HBV-MPL Formulation A at month 0 and Engerix™-B at month 6
HBV-MPL vaccine Formulation A
Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection
Engerix™-B
Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection
Group D
Engerix™-B at months 0, 1, 6
Engerix™-B
Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection
Interventions
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HBV-MPL vaccine Formulation A
Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection
HBV-MPL vaccine Formulation B
2-dose intramuscular injection
Engerix™-B
Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
11 Years
15 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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GSK
Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Clinical Trials Call Center
Mainz, , Germany
Countries
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Other Identifiers
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208129/028
Identifier Type: -
Identifier Source: org_study_id