跳至主要内容
临床试验/EUCTR2013-005355-32-NL
EUCTR2013-005355-32-NL进行中(未招募)1 期

Memory response against Bordetella pertussis in adults: immunological effects of an acellular pertussis booster vaccination - VIKING-study

ational Institute for Public Health and the Environment (RIVM, the Netherlands)0 个研究点目标入组 100 人开始时间: 2014年2月24日最近更新:
适应症
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
100

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

  • 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.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • 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) no
  • F.1.3.1 Number of subjects for this age range

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 history);
  • 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

发起方
ational Institute for Public Health and the Environment (RIVM, the Netherlands)

相似试验