EUCTR2018-002976-41-NL进行中（未招募）1 期
‘Premature infants and maternal pertussis immunization. Is second trimester vaccination beneficial?’ - PIMPI: Premature Infants and Maternal Pertussis Immunization
RIVM0 个研究点目标入组 120 人开始时间: 2019年7月24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
- 120
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
入选标准
- •1.18 years or older
- •2.Being pregnant
- •3.Having an antenatal appointment with a midwife or obstetrician in the 1st trimester of pregnancy
- •4.Signed informed consent
- •5.Parents who are willing to adhere to the protocol and perform all planned visits and
- •sample collections for themselves and their newborn child (only relevant for the immunogenicity part
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.All women with one or more missing inclusion criteria
- •2.History of having received a pertussis containing vaccination in the past 2 years.
- •3.History of having had pertussis disease in the past 5 years.
- •4.Known or suspected serious underlying condition that can interfere with the results
- •of the study such as but not limited to cancer, autoimmune disease, immunodeficiency, seizure disorder or significant psychiatric illness.
- •5.Receipt of any high-dose (=20 mg of prednisone daily or equivalent) daily corticosteroids within 2 weeks of study entry (inhaled or other local steroids are acceptable) with exception of corticosteroids to enhance maturation of fetal lungs in case of imminent early delivery.
- •6.Receipt of other immune modulating medication, for instance biologicals.
- •7.Receipt of blood products or immunoglobulins, within three months of study entry
- •(Rhesus negative women who receive anti-rhesus (D)- immunoglobulin will not be
- •excluded from the study).
- •8.Presence of bleeding disorder.
- •9.Having experienced a previous severe adverse reaction to any vaccine.
- •10.Receipt of any vaccine(s) within 2 weeks of study vaccine (except influenza
- •vaccine which may be given concomitantly).
研究者
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