EUCTR2019-001301-24-NL进行中（未招募）1 期
‘Primary and booster meningococcal vaccination in Dutch elderly: study to investigate the immune response and determine functional antibodies after the tetravalent MenACWY-TT conjugate vaccine in the elderly population’ - Men4age study
ational Institute for Public Health and the Environment (RIVM)0 个研究点目标入组 140 人开始时间: 2020年2月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
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
- •Participants eligible for this study are healthy Dutch elderly 65-85 years of age, who did not receive a MenACWY-TT vaccine before.
- •Are the trial subjects under 18? no
- •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) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •?Antibiotic use within 14 days of enrolment
- •?Severe acute infectious illness or fever above 38.0 °C within 14 days before vaccination;
- •?Present evidence of serious diseases either demanding regular use of oral immunosuppressive medical treatment, like corticosteroids, that might interfere with the results of the study within the last 3 months or demanding acute use of high dose oral immunosuppressive that might interfere with the results of the study within the last 2 weeks;
- •?Known or suspected allergy to any of the vaccine components (by medical history);
- •?Occurrence of a serious adverse event after other vaccination by medical history;
- •?Known or suspected immune deficiency;
- •?Known or suspected coagulation disorder;
- •?Oral hormone use, such as postmenopausal hormones, within the last 3 months;
- •?History of one of the following neurological disorders: multiple sclerosis, Parkinson’s disease, or epilepsy;
- •?Previous administration of plasma-serum products including immunoglobulins within 6 months before vaccination and blood sampling;
- •?Serious surgery within the last 3 months;
- •?Previous vaccination with the MenC, MenC-TT or MenACWY-TT vaccine;
- •?Previous confirmed or suspected meningococcal disease;
- •?Any vaccination within a month before enrolment.
- •Presence of in-and exclusion criteria will be checked by interviewing the participant during the first phone call. In addition, presence of in-and exclusion criteria will be checked at the first study visit again, prior to signing the informed consent.
研究者
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尚未招募
不适用
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