EUCTR2012-005641-21-Outside-EU/EEA进行中（未招募）不适用
A phase III, open, controlled study to assess the persistence of antibodies after one dose of GlaxoSmithKline Biologicals’ meningococcal serogroup ACWY conjugate vaccine (MenACWY-TT) given intramuscularly versus one dose of Mencevax™ ACWY given subcutaneously to healthy subjects aged 11 through 17 years in the primary study 109069 (MenACWY-TT-036) - MENACWY-TT-043 EXT: 036 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
- 689
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 they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol
- •A male or female having been vaccinated with a meningococcal vaccine in the primary study 109069 (MENACWY-TT-036)
- •Written informed consent obtained from parent(s)/guardian(s) of the subject and written informed as-sent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday
- •Healthy subjects as established by medical history and clinical examination before entering into the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 689
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 259
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the subject’s first visit
- •History of meningococcal disease
- •Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since previous vaccination in study 109069 (MENACWY-TT-036)
- •Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history
- •Administration of immunoglobulines and/or any blood products within the three months preceding the subject’s first visit
- •Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy
- •Subjects who withdrew consent to be contacted for follow-up studies
研究者
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