EUCTR2016-003678-42-GB进行中(未招募)1 期
Immunological effects of an acellular pertussis booster vaccination in children, young adults and elderly with different immunisation background.An international study in Finland, the Netherlands and the United Kingdom - Booster Against Pertussis (BERT) Study
CTRG, University of Oxford0 个研究点目标入组 366 人开始时间: 2018年6月8日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 366
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 NIP, UK NIP or Finnish NIP
- •Provision of written informed consent
- •Willing to adhere to the protocol and be available during the study period
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 216
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
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 and/or suspected allergy to any of the vaccine components (by medical history);
- •Occurrence of a serious adverse events (SAEs) after primary DTwP-IPV vaccination, DTaP-IPV vaccination or any other vaccination (by medical history);
- •Vaccination with any other pertussis vaccine other than those described in the inclusion criteria (i.e. only according to NIP)
- •Vaccination with any other DT-IPV vaccine in the last 5 years, a DT-IPV vaccination according to NIP in cohort B is not an exclusion criterion;
- •Children between 8 and 10 years of age eligible for cohort A in the Netherlands who have already received the diphtheria and tetanus toxoid vaccine (DT)-IPV booster vaccination according to Dutch NIP around 9 years of age;
- •Mixed wP and aP priming within a participant, cohort B;
- •Pregnancy.
研究者
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