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临床试验/CTIS2022-500752-39-00
CTIS2022-500752-39-00进行中(未招募)1 期

A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease - MK-1654-007

Merck Sharp & Dohme LLC0 个研究点目标入组 936 人开始时间: 2023年3月31日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
936

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

年龄范围
0 至 17(—)
性别
All

入选标准

  • Participants at increased risk for severe respiratory syncytial virus (RSV) infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations., Is available to complete the follow-up period., Is male or female and has a chronological age from birth up to 1 year and is entering their first RSV season.

排除标准

  • Requires mechanical ventilation at time of enrollment., Has a life expectancy <6 months., Has known hepatic or renal dysfunction, or chronic seizure disorder., Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization., Has severe immunodeficiency or is severely immunocompromised., Has known hypersensitivity to any component of clesrovimab or palivizumab.

研究者

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