NL-OMON26652招募中不适用
Meningococcal vaccination in Dutch teenagers and adolescents: Study to investigate the long-term immune response after a tetravalent MenACWY-TT conjugate vaccine.
ational Institute for Public Health and Environment (RIVM)0 个研究点目标入组 221 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 221
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
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria: participants from the JIM-study were 10, 12 or 15 years old at time of vaccination with a MenACWY-TT vaccine after they received a primary vaccination with a single dose of MenC-TT vaccine (NeisVac-CTM) either during the mass catch-up campaign in 2002 (group 3) or at the age of 14 months according to the Dutch NIP (group 1, 2 or 3). Furthermore, in order to be eligible to participate in this study, a participant must meet all of the following criteria:
- •- Provision of written informed consent by the participant and, if the participant is under 16, also by its parent(s) or caregiver(s)
- •- Good general health
- •- Received all regular vaccines according to the Dutch NIP
- •- Adherent to protocol, and available during the study period
排除标准
- •Any of the following criteria at the start of the study will exclude a potential subject from participation in this study:
- •- Previous administration of plasma products (including immunoglobulins) within the last 6 months;
- •- Pregnancy;
- •- Previous confirmed or suspected meningococcal disease;
- •- Received any vaccination in the past month;
- •- Former received tetravalent MenACWY vaccination administered not as part of the JIM-study
- •- Known or suspected immune deficiency;
- •- History of any neurologic disorder, including epilepsy;
- •- Present evidence of serious disease(s) demanding (immunosuppressive) medical treatment that might interfere with the results of the study within the last 3 months (like corticosteroids, chronic infection, bleeding disorder, immune dysfunction, or genetic anomaly).
- •In the JIM-study, in addition, any of the following criteria excluded a potential subject from participation in the study:
- •- Severe acute (infectious) illness or fever (>38.5°C) within 14 days before vaccination;
- •- Antibiotic use within 14 days of enrollment;
- •- Known or suspected allergy to any of the vaccine components (by medical history);
- •- Occurrence of serious adverse event after primary MenC-TT vaccination or other vaccination (by medical history)
- •- Former received doses of MenC vaccines in addition to the primary vaccination;
- •- Former received any tetravalent MenACWY vaccination;
- •NL68774.100.19 / IIV-401 JIM2-study
- •Version number: 2 April 15, 2019 14 of 27
- •The participants included in the JIM-study did not meet these exclusion criteria at time of the JIM-study.
研究者
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