EUCTR2015-001517-27-Outside-EU/EEAActive, not recruitingNot Applicable
An open multicentre, multicountry study to evaluate long-term anti-body persistence and immune memory between Years 11 and 15 after the primary study HAB-084 in which healthy adolescents were vaccinated with Twinrix™ Adult following a two-dose schedule or Twinrix™ Junior following a three-dose schedule. - HAB-084, HAB-153EXT:084Y6, HAB-154EXT:084Y7, HAB-155EXT:084Y8, HAB-156EXT:084Y9, HAB-157EXT:084Y10
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •For primary study:
- •Healthy male and female volunteers between the ages of 12-15 years at first vaccination will be enrolled in this study.
- •Negative titres for anti-HAV, anti-HBs, anti-HBc antibodies and / or HBsAg.
- •Age: between 12 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 parent / guardian of the subject.
- •If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions.
- •For the LTFU:
- •Subjects who had received at least one dose of the study vaccine in the primary study HAB-084.
- •Written informed consent was obtained from each subject or parent/guardian of the subject before the first blood-sampling visit of the follow-up.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 300
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Use of any investigational or non-registered drug or vac-cine other than the study vaccines during the study period or within 30 days preceding the first dose of study vaccine.
- •Administration of chronic immunosuppressants or other immune-modifying drugs within six months.
- •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 A or hepatitis B.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
- •Family history of congenital or hereditary immunodeficiency
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease at the time of enrollment.
- •Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- •Oral or 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.
Investigators
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