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
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
- 否
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
研究点 (4)
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