A phase III, single centre, double blind, randomised study evaluating the consistency of three lots of Henogen’s new adjuvanted hepatitis B vaccine HB-AS02V, when administered according to a 0, 1 month schedule in healthy volunteers aged 18 years to 40 years. - HN016/HBV-002
- Conditions
- o medical condition, healthy subjects
- Registration Number
- EUCTR2005-004057-98-CZ
- Lead Sponsor
- Henogen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
·Subjects who the investigator believes that they 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.
·A male or female adult aged between 18 and 40 years, inclusive, of age at the time of the first vaccination.
·Written informed consent obtained from the subject
·Healthy subjects as established by medical history and clinical examination before entering into the study.
·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? 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)
F.1.3.1 Number of subjects for this age range
·Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use 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, superior or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
·Planned administration/ administration of a vaccine not foreseen by the study protocol within 14 days (killed vaccine) or 30 days (attenuated/ live vaccine) before the first vaccine dose.
·Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
·Prior vaccination against hepatitis B.
·History of hepatitis B infection.
·Known exposure to hepatitis B virus within 6 months.
·Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
·History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
·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 °C.
·Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
·Pregnant or lactating female.
·Female planning to become pregnant or planning to discontinue contraceptive precautions.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To demonstrate the lot-to-lot consistency of three manufacturing lots of HB-AS02V, in terms of anti-HBs seroprotection rates (anti-HBs antibody concentrations ³ 10 mIU/ml) at Month 2 .;Secondary Objective: -·To evaluate the lot-to-lot consistency of HB-AS02V, in terms of anti-HBs antibody GMC at Month 2. <br>-·To evaluate the immunogenicity of HB-AS02V, in terms of seropositivity rates (percentage of subjects with anti-HBs antibody concentrations ³ 3.3 mIU/ml), seroprotection rates, GMCs and percentage of subjects with anti-HBs antibody concentrations ³ 100 mIU/ml at all time points.<br>-·To evaluate the safety and reactogenicity of the HB-AS02V vaccine after each dose and per subject.;Primary end point(s): ·Anti-HBs seroprotection rates (percentage of subjects with anti-HBs antibody concentrations superior or equal to 10 mIU/ml) at Month 2.<br>
- Secondary Outcome Measures
Name Time Method