NL-OMON45409已完成4 期
Immunological effects of an acellular pertussis booster vaccination in children, young adults and elderly with different immunisation background.<br>An international study in Finland, the Netherlands and the United Kingdom - Booster against pertussis (Bert)
RIVM0 个研究点目标入组 134 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
- 134
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
- 2 至 64(—)
入选标准
- •* normal general health;
- •* within the right age group for the cohort;
- •* received all regular vaccines for their age group according to the Dutch National immunisation programme (NIP), UK NIP or Finnish NIP; a copy of the vaccination booklet will be included in the participant*s documents. If booklet is not available for cohorts A, B and C, vaccination status will be checked with regulatory agencies / General practitioner. For cohort D this booklet might not be available due to their age;
- •* provision of written informed consent (see section 11.2 for details);
- •* willing to adhere to the protocol and be available during the study period.
排除标准
- •* present evidence of serious disease(s) within the last 3 months before inclusion requiring immunosuppressive or immune modulating medical treatment, such as systemic corticosteroids, that might interfere with the results of the study;
- •* chronic infection;
- •* 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 sampling;
- •* known or suspected allergy to any of the vaccine components (by medical history);
- •* occurrence of serious adverse events (SAEs) after primary DTwP-IPV (Diphtheria, Tetanus, whole-cell Pertussis, Polio) vaccination, DTaP-IPV (Diphtheria, Tetanus, acellular Pertussis, Polio) vaccination or any other vaccination (by medical history);
- •* vaccination with any other pertussis vaccine than those described in the inclusion criteria (i.e. only according to NIP);
- •* vaccination with any other Diphtheria, Tetanus and polio (DT-IPV) vaccine in the last 5 years, DT-IPV vaccination according to NIP in cohort B is no exclusion;
- •* children between 8 and 10 years of age eligible for cohort A in the Netherlands who have already received the DT-IPV booster vaccination according to the Dutch NIP around 9 years of age;
- •* mixed whole-cell pertussis (wP) and acellular pertussis (aP) priming within a participant, cohort B;
- •* Pregnancy
研究者
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