NCT01024400已完成2 期
Etude de Phase II évaluant l'immunogénicité et la tolérance d'un Vaccin inactivé Non adjuvanté Contre la Grippe A(H1N1)v Chez la Femme Enceinte
Institut National de la Santé Et de la Recherche Médicale, France5 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2009年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 5
- 主要终点
- Immunogenicity: proportion of subjects achieving a serum HAI antibody titer of greater than or equal to 1:40, proportion of subjects with 4-fold or greater HAI antibody titer increases against H1N1 2009 virus following H1N1 vaccine.
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and safety of an inactivated, non adjuvanted A(H1N1)v influenza vaccine in 120 pregnant women.
Study procedures will include 2 doses of vaccine, blood samples, cord blood samples at delivery and recording temperature and vaccine side effects in a memory aid for 7 days following each vaccination. Participants will be involved in study related procedures about 3 at 5 months.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years to 45 years
- •Pregnancy between 22 and 32 weeks of gestation
- •Provides written informed consent
- •Covered by French Social Security
排除标准
- •Allergy to eggs or other components in the vaccine
- •History of severe reactions following previous influenza vaccines
- •H1N1 influenza (virologically documented) during the last 6 months
- •Febrile episode within one week prior to vaccination
- •Known HIV, HBV, HCV infection
- •Multiple sclerosis
- •History of Guillain-Barré syndrome
- •Organ transplant recipient
- •Neoplastic disease in the past 3 years
- •Other vaccine within 3 weeks prior to study entry or planned within the month following the last injection
- •Systemic corticosteroids,immunotherapy,chemotherapy
- •Anticoagulant treatment
- •Immunoglobulin or blood transfusion within the 3 months prior to enrollment in this study
- •History of cardiac disease
- •Chronic liver disease
- •Diabetes before pregnancy
- •History of premature delivery
- •History of eclampsia
- •Fetal morphologic abnormalities
研究组 & 干预措施
vaccine
Experimental
干预措施: Non-adjuvanted A(H1N1)v influenza vaccine (Biological)
结局指标
主要结局
Immunogenicity: proportion of subjects achieving a serum HAI antibody titer of greater than or equal to 1:40, proportion of subjects with 4-fold or greater HAI antibody titer increases against H1N1 2009 virus following H1N1 vaccine.
时间窗: Day 21
次要结局
- Safety: occurence of local and systemic adverse events(Throughout the course of the study)
- Immunogenicity: proportion of subjects achieving a serum HAI antibody titer of greater than or equal to 1:40, proportion of subjects with 4-fold or greater HAI antibody titer increases against H1N1 2009 virus following H1N1 vaccine.(Day 42 and at delivery)
- Safety:occurence of vaccine-associated serious adverse events(Throughout the course of the study)
研究者
研究点 (5)
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