NL-OMON50704已完成4 期
Memory response against Bordetella pertussis in adults: immunological effects of an acellular pertussis booster vaccination - VIKING-study
RIVM0 个研究点目标入组 106 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
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
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, participants must meet
- •all of the following criteria:
- •Good general health;
- •25-29 years of age;
- •Vaccinated with DTwP-IPV (RIVM) at 3, 4, 5, and 11 months of age;
- •Received all other regular vaccines according to the Dutch NIP;
- •Provision of written informed consent;
- •Adherent to protocol and available during the study period.
排除标准
- •Any of the following criteria will exclude a participant from this study:
- •Antibiotic use within 14 days of enrollment;
- •Present evidence of serious disease(s) demanding immunosuppressive medical
- •treatment, like corticosteroids, that might interfere with the results of the
- •study within the last 3 months;
- •Known or suspected allergy to any of the vaccine components (by medical
- •Occurrence of serious adverse event after primary DTwP-IPV vaccination or
- •other vaccination (by medical history);
- •Known or suspected immune deficiency;
- •History of any neurologic disorder, including epilepsy;
- •Previous administration of serum products (including immunoglobulins) within
- •6 months before vaccination and blood/ saliva sampling;
- •Vaccination with any other pertussis vaccine than those described in the
- •inclusion criteria;
- •No DT or DT-IPV vaccination at least 5 years before enrollment;
- •Vaccination within a month before enrollment;
- •Pregnant at start of study (when vaccination is administered);
研究者
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