A phase III multicentric, multinational, controlled, randomised, open study comparing the immunogenicity, reactogenicity and safety of Henogen’s new adjuvanted hepatitis B vaccine, HB-AS02V, to that of Aventis Pasteur MSD’s hepatitis B vaccine, HBVAXPRO®, administered according to a 0, 1 months schedule, in pre-dialysis, peritoneal dialysis and haemodialysis patients (above or equal to 15 years of age), who did not respond to previous hepatitis B vaccination. - HN017/HBV-003

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

A male or female subject = 15 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject/ subject’s parents or guardian.
• Subjects who the investigator believes that they and/or their parents/guardians can
and will comply with the requirements of the protocol (e.g. completion of the diary
cards, return for follow-up visits) should be enrolled in the study.
• Seronegative for anti-HBc antibodies and HBsAg at screening.
• Pre-dialysis, peritoneal dialysis or haemodialysis patients. Pre-dialysis patient is
defined as a patient with a documented creatinine clearance of = 30 ml/min as
estimated by the Cockroft-Gault formula.
• Documented evidence of previous hepatitis B vaccination with at least one full
primary vaccination course of minimum four injections of licensed vaccine. The last
dose should have been administered at least two months before the planned first dose
of study vaccine in this study.
• Documented evidence of non-response to previous hepatitis B vaccination (nonresponse
defined as anti-HBs antibody < 10mIU/ml) after at least one to maximum
three months after the last vaccine dose.
• If the subject is female, 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 medically-approved 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? yes
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

Subjects who have been included in the HN014/HBV-001 study.
HN017/HBV-003
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Use of any investigational or non-registered drug or vaccine within 30 days
preceding the first dose of study vaccine, or planned use during the study period.
• Use of any registered vaccine within 7 days preceding the first dose of study vaccine.
• History of hepatitis B infection.
• Known exposure to hepatitis B virus within 6 months.
• Use of immunoglobulins within six months preceding the first dose of study vaccine.
• Immunosuppression caused by the administration of parenteral steroids or
chemotherapy (oral steroids are allowed).
• Any confirmed or suspected human immunodeficiency virus (HIV) infection.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of
the vaccines.
• Acute disease at the time of enrolment. (Acute disease is defined as the presence of a
moderate or severe illness with or without fever. All vaccines can be administered to
persons with a minor illness such as diarrhoea, mild upper respiratory infection with
or without low-grade febrile illness, i.e., oral/ axillary temperature < 37.5°C (or 37°C
in Czech Republic).
• Oral/axillary temperature = 37.5°C (or 37°C in Czech Republic).
• Pregnant or lactating female