A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)

MedImmune, LLC0 个研究点目标入组 925 人开始时间: 2019年7月11日最近更新: 2021年6月28日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: MedImmune, LLC
入组人数: 925

研究概览入排标准研究者记录与标识符相似试验

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

性别: All

入选标准

•Subjects must meet all of the following criteria:
•1. For the preterm cohort (excluding subjects with CLD or hemodynamically significant CHD): preterm infants in their first year of life and born = 35 weeks 0 days GA eligible to receive palivizumab in accordance with national or local guidelines, including those with:
•(a) Uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, or
•(b) Aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone
•2. For the CLD/CHD cohort:
•(a) Subjects with CLD - infants in their first year of life and a diagnosis of CLD of prematurity requiring medical intervention/management (ie, supplemental oxygen, bronchodilators, or diuretics) within the 6 months prior to randomization
•(b) Subjects with CHD - infants in their first year of life and documented, hemodynamically significant CHD (must be unoperated or partially corrected CHD) Note: Infants with hemodynamically significant acyanotic cardiac lesions must have pulmonary hypertension (= 40 mmHg measured pressure in the pulmonary artery) or the need for daily medication to manage CHD
•3. Infants who are entering their first RSV season at the time of screening
•4. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the USA, EU Data Privacy Directive in the EU) obtained from the subject's parent(s)/legal representative(s) prior to performing any protocol-related procedures, including screening evaluations
•5. Subject's parent(s)/legal representative(s) able to understand and comply with the requirements of the protocol including follow-up and illness visits as judged by the investigator
•6. Subject is available to complete the follow-up period, which will be 1 year after Season 1/ Dose 1 for subjects without CLD/CHD, or 1 year after Season 2/Dose 1 (or last replacement dose as applicable for CHD) for subjects with CLD/CHD
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 925
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•Any of the following would exclude the subject from participation in the study:
•1. Any fever (= 100.4°F [= 38.0°C], regardless of route) or acute illness within 7 days prior to randomization
•2. Any history of LRTI or active LRTI prior to, or at the time of, randomization
•3. Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
•4. Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization
•5. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, CPAP, or other mechanical respiratory or cardiac support at the time of randomization
•6. Anticipated cardiac surgery within 2 weeks after randomization
•7. Anticipated survival of < 6 months after randomization
•8. Receipt of any investigational drug
•9. Known renal impairment
•10. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
•11. Clinically significant congenital anomaly of the respiratory tract
•12. Chronic seizure, or evolving or unstable neurologic disorder
•13. Prior history of a suspected or actual acute life-threatening event
•14. Known immunodeficiency, including human immunodeficiency virus (HIV)
•15. Mother with HIV infection (unless the child has been proven to be not infected)
•16. Any known allergy, including to immunoglobulin products, or history of allergic reaction
•17. Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination
•18. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study
•19. Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results
•20. Concurrent enrollment in another interventional study
•21. Children of employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals

研究者

发起方

MedImmune, LLC

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