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临床试验/EUCTR2016-003678-42-GB
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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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

发起方
CTRG, University of Oxford

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