EUCTR2014-004367-20-FI进行中（未招募）不适用
A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccines in Healthy Toddlers
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
- •1) Aged 12 to 23 months on the day of the first study visit
- •2) Born at full term of pregnancy (= 37 weeks) or with a birth weight = 2.5 kg (5.5 pounds)
- •3) Informed consent form (ICF) has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)
- •4) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
- •5) Covered by health insurance where applicable
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 200
- •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
- •An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
- •1) Participation at the time of study enrollment (or 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 before the final blood draw except for influenza vaccination, which may be received at least 2 weeks before or after the study vaccines
- •3) Previous vaccination against meningococcal disease with either the trial vaccine or mono-, or polyvalent polysaccharide or conjugate meningococcal vaccine containing serogroups A, B, C, W, or Y
- •4) Receipt of immune globulins, blood, or blood-derived products in the past 3 months
- •5) 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 (= 2mg/kg/day of prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •6) History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
- •7) At high risk for meningococcal infection during the trial (i.e., subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease)
- •8) Known systemic hypersensitivity to any of the vaccine components, history of a life-threatening reaction to the vaccines used in the trial, or to a vaccine containing any of the same substances
- •9) Known systemic hypersensitivity to latex
- •10) Known thrombocytopenia, as reported by the parent/legally acceptable representative
- •11) Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
- •12) Personal history of Guillain-Barré syndrome (GBS)
- •13) Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
- •14) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- •15) Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
- •16) Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
- •17) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
研究者
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