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临床试验/CTIS2024-513640-29-00
CTIS2024-513640-29-00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 - IIV-407

Rijksinstituut voor Volksgezondheid en Milieu (RIVM)0 个研究点目标入组 280 人开始时间: 2024年4月26日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
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 65+(—)
性别
All

入选标准

  • Participants eligible for this study are Dutch older persons 65-85 years of age, Moderate to good general health with regard to age, Did not receive a MenACWY-TT vaccine before

排除标准

  • Antibiotic use within 14 days of enrolment, 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, Known or suspected allergy to any of the vaccine components (by medical history), 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, 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

研究者

发起方
Rijksinstituut voor Volksgezondheid en Milieu (RIVM)

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