NL-OMON54103招募中4 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
RIVM0 个研究点目标入组 280 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 280
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
- 年龄范围
- 65 至 99（—）
入选标准
- •Participants eligible for this study are Dutch older persons 65-85 years of
- •age, of moderate to good general health with regard to age, who did not receive
- •a MenACWY-TT vaccine before.
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
- •* Occurrence of a serious adverse event after other vaccination by medical
- •* 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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