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临床试验/NL-OMON21026
NL-OMON21026招募中不适用

Preterm infants and second trimester maternal pertussis vaccination

RIVM, UMC0 个研究点目标入组 6,750 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
6,750

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 18 years or older; being pregnant; having an antenatal appointment with a midwife or obstetrician in the 1st trimester of pregnancy; parents who are willing to adhere to the protocol and perform all planned visits and sample collections for themselves and their newborn child.

排除标准

  • History of having received a pertussis containing vaccination in the past 2 years; history of having had pertussis disease in the past 5 years; 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; receipt of any high-dose daily corticosteroids within 2 weeks of study entry with exception of corticosteroids to enhance maturation of fetal lungs in case of imminent early delivery; receipt of other immune modulation medication, for instance biologicals; receipt of blood products or immunoglobulins within three months of study entry; bleeding disorder; having experienced a previous severe adverse reaction to any vaccine; receipt of any vaccine(s) within 2 weeks of study vaccine (except influenza vaccine).

研究者

发起方
RIVM, UMC

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