Vaccination against hepatitis B virus in healthy adults aged equal to or greater than 18 years at the time of first vaccination.
Conditions
Interventions
Trade Name: Engerix-B
Product Name: Engerix-B
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Hepatitis B surface antigen
Concentration unit: µg/ml microgram(s)/millilitre
Concentr
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female adult aged greater than or equal to 18 years, who is free from obvious health problems and from whom written informed consent is obtained. If the subject is a female then she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine. Previous vaccination against hepatitis B History of hepatitis B infection Acute disease at the time of enrolment. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority of multidose Engerix™-B to monodose Engerix™-B in terms of anti-HBs seroprotection rate elicited one month after complete vaccination course (i.e. at Month 7).;Secondary Objective: To evaluate the anti-HBs antibody concentrations at Months 1, 2 and 6 and to evaluate reactogenicity and safety after each vaccine dose. ;Primary end point(s): Anti-HBs seroprotection rates (defined as percentage of subjects with anti-HBs antibody concentrations greater than or equal to 10 mIU/ml) at Month 7. | — |
Countries
Belgium
Outcome results
None listed