EUCTR2015-005189-48-Outside-EU/EEA进行中（未招募）不适用
Safety and Immunogenicity of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine versus Lanzhou Institute of Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine in Children 2-6 Years of Age in China
Sanofi Pasteur SA0 个研究点目标入组 665 人开始时间: 2015年11月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 665
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
- •1. Aged 2 to 6 years on the day of inclusion
- •2. Informed consent form has been signed and dated by the parent or another legally acceptable representative
- •3. Subject and parent/ legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
- •4. Written documentation of immunization history against meningococcal disease according to the national Expanded Program on Immunization (EPI) schedule (including 2 doses with Meningococcal Group A Polysaccharide Vaccine between 6 and 18 months of age).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 665
- •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
- •1)Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- •2)Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination (except for influenza vaccination, which may be received at least 2 weeks before study vaccines).
- •3)Previous vaccination against meningococcal disease within the past 12 months with either the trial vaccine or another vaccine.
- •4)Previous vaccination with any meningococcal conjugate vaccine.
- •5)Receipt of immune globulins, blood or blood-derived products in the past 3 months.
- •6)Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •7)History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
- •8)At high risk for meningococcal disease during the trial, including:
- •a)persons with increased susceptibility such as persistent complement component deficiencies,
- •b)persons with anatomic or functional asplenia,
- •c)persons who have exposure (e.g., microbiologists routinely working with Neisseria meningitidis, or travelers to or residents of areas where meningococcal disease is hyperendemic or epidemic).
- •9)Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
- •10)Known thrombocytopenia, as reported by the parent/legally acceptable representative, contraindicating intramuscular vaccination.
- •11)Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
- •12)Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- •13)Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
- •14)Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature = 37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
- •15)Receipt of oral or injected antibiotic therapy within 72 hours before the first blood draw.
- •16)Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
- •17)Any contraindication as listed in the study vaccines leaflets.
研究者
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