Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents
Phase 2
Completed
- Conditions
- Hepatitis B
- Registration Number
- NCT00697775
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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
- Detailed Description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Anti-HBs antibody concentrations At months 1, 2, 6, and 7 Cell mediated immunity At months 1, 6, and 7
Trial Locations
- Locations (1)
GSK Clinical Trials Call Center
🇩🇪Mainz, Germany
GSK Clinical Trials Call Center🇩🇪Mainz, Germany