A pivotal phase 3 study of MEDI-524 (Numax), an enhanced potency humanized respiratory syncytial virus (RSV) monoclonal antibody, for the prophylaxis of serious RSV disease in high-risk children.

MedImmune, Inc.0 个研究点目标入组 6,600 人开始时间: 2004年11月18日最近更新: 2013年4月22日

研究概览

暂无简介。

•1. 24 months of age or younger at randomization (child must be randomized on or before their 24-month birthday) with a diagnosis of Chronic Lung Disease of prematurity requiring medical intervention / management (i.e., supplemental oxygen, bronchodilators, or diuretics) within the 6 months before randomization
•35 weeks gestational age or less at birth and 6 months of age or younger at randomization (child must be randomized on or before their 6-month birthday)
•2. Written informed consent obtained from the patient’s parent(s) or legal guardian
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•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

•Children must have none of the following:
•1. Hospitalization at the time of randomization (unless discharge is anticipated within 10 days)
•2. Mechanical ventilation or other mechanical support (including CPAP)
•3. Life expectancy <6 months
•4. Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing)
•5. Known renal impairment
•6. Known hepatic dysfunction
•7. Chronic seizure evolving or unstable or neurologic disorder
•8. Congenital heart disease (children with uncomplicated CHD [e.g., PDA, small septal defect] and children with complicated CHD who are currently anatomically and hemodynamically normal can be enrolled.)
•9. Known immunodeficiency
•10. Mother with HIV infection (unless the child has been proven to be not infected)
•11. Known allergy to Ig products
•12. Receipt of palivizumab, RSV-IGIV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
•13. Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted)
•14. Previous receipt of RSV vaccines
•15. Participation in other investigational drug product studies

发起方