NCT02775422终止不适用
Comparison of Serological Tests for the Varicella-zoster Virus and Correlation With the Memory of the Infection or Vaccination
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 308
- 试验地点
- 2
- 主要终点
- Rate sensitivity and specificity in negative and dubious zone for the assessment of the serology of anti VZV immunity
研究概览
简要总结
Comparison of the sensibility and specificity of 3 different serological tests and evaluation of chicken pox immunity in pregnant women.
Secondary goals :
- Correlation memory / Immunity;
- Prevalence of VZV immunity in pregnant women;
- Evaluation of cellular and humoral immunity in cases with discrepancy between tests or between test and memory;
- Evaluation of acceptability of vaccination in the post partum period in non immune patients.
Methods Not randomized prospective study,
Number of patients : 400 Duration : 36 months Inclusion criteria : pregnant women >18years old, agree to participate (written consent) Exclusion criteria: auto immune disease, HIV +, grafted patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Pregnant women aged over 18
- •Affiliated to a social protection scheme or women benefiting from such a regime
- •Women who gived a writing consent
排除标准
- •Women with a maternal disease: autoimmune disease (systemic lupus erythematosus, antiphospholipid syndrome, insulin dependent diabetes, autoimmune thyroiditis ..), it takes an immunosuppressive treatment or not.
- •HIV-positive women
- •Garfted women whatever organ
结局指标
主要结局
Rate sensitivity and specificity in negative and dubious zone for the assessment of the serology of anti VZV immunity
时间窗: 35 weeks
次要结局
- frequency of immunity detecting depending on whether the patient remember having varicella, have been in contact with next of kin with varicella or been vaccinated against varicella or not(up to 35 weeks)
- Percentage of women accepting the vaccination in case of negative history(day during the first visit)
研究者
研究点 (2)
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