Effect of intranasal administration of palivizumab on respiratory syncytial virus-associated infection – a randomized controlled trial - Narsyn

niversity Medical Center Utrecht0 个研究点目标入组 408 人开始时间: 2018年8月15日最近更新: 2021年6月21日

适应症

试验速览

暂无简介。

•Adult men and women between the ages of 18 and 60 in good health based on relevant medical history.
•Healthy preterm infants with gestational age between 32 and 35 weeks and less than 6 months of age at the onset of the RSV season. Children must have a least one sibling. Only children of parents who master the Dutch language are included.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 408
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Adults with a nasal cold or obstructions in the nasal cavity that could interfere with administration of the study vaccine are excluded. History of any respiratory symptoms or clinically significant infectious disease within 4 weeks prior to drug administration or immunocompromised subjects are excluded from the study. Final, nasal surgery prior to or during the trial is an exclusion criterion.
•Children with a known cardiac anomaly, Down syndrome or other serious congenital disorders and children who received surfactant treatment are excluded from the study.

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