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临床试验/EUCTR2008-004489-23-NL
EUCTR2008-004489-23-NL进行中(未招募)1 期

Development of cellular immune response after infant pneumococcal conjugate vaccinations - Pneumococcal cellular immune response

etherlands Vaccine Institute0 个研究点目标入组 100 人开始时间: 2008年7月23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

  • The children have to be of normal health (same health criteria apply as used in well-baby clinics when a child receives a vaccination, e.g. also children with small increases in temperature or cold are seen as children with normal health)
  • They have to be willing and able to participate in the trial according to procedure
  • Presence of a signed informed consent (the parents/legally representatives have
  • given written informed consent after receiving oral and written information)
  • The children have received or will receive the Prevenar® vaccinations according to the 3+1 schedule of the Dutch NIP
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Previous vaccinations with Prevenar® using a schedule that differs from the Dutch 3+1 schedule
  • Previous vaccinations with other pneumoccocal vaccines
  • Presence of a serious disease that requires medical care that can interfere with the results of the study
  • Known or expected allergy/hypersensitivity against one of the vaccine ingredients
  • (anamnestic, be alert if the child has had medical complaints after previous Prevenar® vaccinations)
  • Known or suspected immunological disorder
  • Previously administration of plasma products (including immunoglobulin), within three months of study enrolment
  • Bleeding disorders

研究者

发起方
etherlands Vaccine Institute

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