NL-OMON20287尚未招募不适用
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’
ational Institute for Public Health and the Environment0 个研究点目标入组 140 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 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
入排标准
入选标准
- •? Moderate to good general health with regard to age;
- •? 65-85 years of age;
- •? Provision of written informed consent;
- •? Adherent to the protocol and available during the study period.
排除标准
- •? 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.
研究者
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