NL-OMON48391已完成不适用
Meningococcal vaccination in Dutch teenagers and adolescents: Study to investigate the long-term immune response after a tetravalent MenACWY-TT conjugate vaccine. - JIM2-study
RIVM0 个研究点目标入组 55 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
- 已完成
- 发起方
- 入组人数
- 55
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12 至 99（—）
入选标准
- •Participants are former participants of the JIM-study (2014) and all received a primary vaccination with a single dose of MenC_PS conjugated (MenC-TT vaccine) either during the mass catch-up campaign in 2002 or at the age of 14 months (regular vaccination time point since 2002 according to the Dutch NIP) and also received a booster vaccination with a MenACWY-TT vaccine at the age of 10, 12, or 15 respectively 5 years ago in the context of the JIM-study.
- •Furthermore, participants will have to fulfil all of the following criteria:
- •- Provision of written informed consent by the participant itself and both parents and if the child is under 16 years old.
- •- Good general health
- •- Received all regular vaccines according to 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;;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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