Hepatitis B
Conditions
Keywords
Hepatitis B, Recombinant hepatitis B vaccine, Adjuvant
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
Interventions
BIOLOGICALHBV-MPL vaccine Formulation A
Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection
BIOLOGICALHBV-MPL vaccine Formulation B
2-dose intramuscular injection
BIOLOGICALEngerix™-B
Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 15 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Anti-HBs antibody concentrations | At months 1, 2, 6, and 7 |
| Cell mediated immunity | At months 1, 6, and 7 |
Countries
Germany
Outcome results
None listed