EUCTR2012-002719-24-Outside-EU/EEA进行中（未招募）不适用
A phase II, open, multi-center study to evaluate the long-term anti-body persistence at 1 year, 3 years and 5 years after the administration of one or two doses of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine in healthy toddlers at 9-12 months of age, and to evaluate the safety and immunogenicity of a booster dose of MenACWY-TT administered 5 years post-primary vaccination and of a primary vaccination of MenACWY-TT in a newly enrolled group, aged 5-6 years, as a naïve control. - MENACWY-TT-062 EXT:055 Y1, 3, 5
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 372
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
- •All subjects must satisfy the following criteria for the per-sistence phase of the study entry:
- •A male or female toddler who was vaccinated 1, 3 or 5 years ago with the last dose of MenACWY-TT in study with NCT number=00471081.
- •Written informed consent obtained from parents/guardian of the subject.
- •Healthy subjects as established by medical history before entering into the study.
- •Having completed the active phase of the vaccination study with NCT number=00471081 (i.e., not withdrawn, had received all planned doses of study vaccines, provided a post-vaccination blood sample after the final dose).
- •All subjects must meet the following criteria prior to receiving the booster vaccination:
- •Written informed consent obtained from parents/guardian of the subject.
- •Subjects who can and will comply with the requirements of the protocol.
- •Subjects who provide a blood sample 5 years after last vaccination in study with NCT number=00471081.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 387
- •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
- •Use of any investigational or non-registered product (drug or vaccine) within 30 days of each persistence timepoint.
- •Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B, C, W-135, and/or Y outside of study with NCT number=00471081.
- •History of any meningococcal disease due to serogroup A, B, C, W-135, or Y.
- •Any confirmed or suspected immunosuppressive or im-munodeficiency condition based on medical history and physical examination (no laboratory testing is required).
- •Administration of immunoglobulins and/or any blood products within the three months preceding each persistence timepoint.
- •Concurrently participating in another clinical study within 30 days of each persistence timepoint, 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.
- •Subjects withdrew consent to be contacted for follow-up studies.
- •Exclusion criteria for booster vaccination at year 5 study entry (to be checked at Year 5)
- •Subjects who were enrolled in the Kaiser Healthcare system in study with NCT number=00471081, but are no longer enrolled.
- •Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the booster vaccina-tion, 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 booster vaccination. (For corticosteroids, this will mean prednisone, or equivalent, = 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
- •Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B, C, W-135, and/or Y outside of study with NCT number=00471081.
- •History of any meningococcal disease due to serogroup A, B, C, W-135, or Y.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history (no laboratory testing is required).
- •Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration during the study period.
- •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).
- •Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
- •Subjects withdrew consent to be contacted for follow-up studies.
- •Hypersensitivity to latex.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s) with the exception of any licensed inactivated influenza vaccine (live attenuated influenza vaccine is not allowed).
- •Previous vaccination with tetanus and diphtheria toxoids within the last month (i.e., Tdap, Td, and TT-containing vaccine).
- •A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- •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 neurological disorders or seizures.
- •Acute disease at the time of vaccination. (Acute disease is defined
研究者
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