EUCTR2008-003824-51-FI进行中（未招募）不适用
A phase III, open, multi-centre, controlled study to evaluate the long-term antibody persistence at 2 years, 3 years and 4 years after a single dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup A, C, W-135, Y- tetanus toxoid conjugate (MenACWY-TT) vaccine versus one dose of Meningitec™ administered in healthy 12 through 23-month old children who were primed in study MenACWY-TT-039 (109670) and to evaluate the immunogenicity and safety of a booster dose of the same meningococcal conjugate vaccine as given in the primary study, 4 years after priming. - MENACWY-TT-048 EXT:039 Y2, 3, 4, 5
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 992
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects who the investigator believes that their parent(s)/guardian(s) 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.
- •Written informed consent obtained from the parent(s) or guardian(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •A male or female having completed the primary study MenACWY-TT-039 (109670) and who was primed with MenACWY-TT or Meningitec vaccines.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
排除标准
- •Exclusion criteria for persistence study entry (i.e. Month 24, 36 or 48):
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the subject’s first visit.
- •History of meningococcal disease*.
- •Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of study MenACWY-TT-039 (109670).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history (no laboratory testing is required).
- •Administration of immunoglobulins and/or blood products within the three months preceding the subjects first visit.
- •Concurrently participating in another clinical study, within 30 days of study entry, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- •Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
- •* Meningococcal disease history has to be documented using a SAE form.
- •Additional exclusion criteria for booster vaccination (to be checked at Month 48):
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination. (For corticosteroids, this will mean prednisone, or equivalent, = 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Hypersensitivity to any vaccine containing diphtheria toxoid or non-toxic diphtheria toxin protein and/or tetanus toxoid.
- •History of hypersensitivity after previous administration of Meningitec or MenACWY-TT in study MenACWY-TT-039 (109670).
- •Hypersensitivity to latex.
- •Planned administration/ administration of a vaccine not foreseen by the protocol within one month before and 30 days after the booster dose.
- •Previous vaccination with tetanus and diphtheria toxoids within the last month (i.e., Tdap, Td and TT-containing vaccine within the last month).
- •History of any neurological disorder or seizures (one episode of febrile convulsion does not constitute an exclusion criteria).
- •Major congenital defects or serious chronic illness.
- •Acute disease at the time of vaccination. 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 temperature < 37.5°C (99.5°F) / Axillary temperature < 37.5°C (99.5°F) / Rectal temperature < 38°C (100.4°F) / Tympanic temperature on oral setting < 37.5°C (99.5°F).
研究者
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