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临床试验/NCT02934295
NCT02934295已完成不适用

Study of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies

Hopital Foch4 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Hopital Foch
入组人数
192
试验地点
4
主要终点
Level of Anti-Rubella Antibody, E1

研究概览

简要总结

The aim of the research is to study humoral and cellular immunity in pregnant women for who the level of rubella virus antibodies is weakly positive, equivocal or negative with the usual laboratory technique.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women over 18
  • Rubella serology negative, ambiguous or weakly positive during a first prenatal consultation and for which the second determination of the immunity anti rubella is necessary after 18 weeks of pregnancy
  • Accepting the rubella vaccination after the childbirth;
  • Accepting a blood test, during a postnatal consultation, 6 in 8 weeks after vaccination, to verify their immunity towards the virus of the rubella.
  • Affiliated to a social security scheme
  • Having given a written consent

排除标准

  • Rubella contracted since the first serology realized during the first prenatal consultation
  • Autoimmune pathologies
  • Intolerance / allergy known about a previous vaccination whatever it is
  • Immunosuppression (HIV, transplants)
  • Injection of multivalent immunoglobulins (except anti-D)

结局指标

主要结局

Level of Anti-Rubella Antibody, E1

时间窗: 8 months

次要结局

未报告次要终点

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (4)

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