EUCTR2012-000825-33-Outside-EU/EEA进行中（未招募）不适用
A Phase 3 Study of MEDI-524 (Motavizumab) for the Prevention of RSV Disease Among Native American Infants in the Southwestern United States
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,100
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
- •6 months of age or younger at randomization (child must be randomized on or before their 6-month birthday)
- •Male or female Native American
- •General state of good health
- •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: 2100
- •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
- •Gestational age less than or equal to 35 weeks
- •Chronic lung disease of prematurity
- •A bleeding diathesis that would preclude IM injections
- •Hospitalization at the time of randomization (unless discharge is anticipated within 10 days)
- •Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
- •A documented wheezing episode before enrollment
- •Known renal impairment
- •Known hepatic dysfunction
- •Clinically significant congenital anomaly of the respiratory tract
- •Chronic seizure or evolving or unstable neurologic disorder
- •Congenital heart disease (children with uncomplicated CHD [e.g., PDA, small septal defect] and children with complicated CHD who are currently anatomically and hemodynamically)
- •Known immunodeficiency
- •Mother with HIV infection (unless the child has been proven to be not infected)
- •Known allergy to Ig products
- •Receipt of palivizumab, RSV-IGIV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B IG, IVIG) within 3 months prior to randomization
- •Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted)
- •Previous receipt of RSV vaccines
- •Participation in other investigational drug product studies
- •Any medical or social condition which, in the opinion of the investigator, would adversely affect monitoring the infant
- •Inability to complete the study follow-up period through up to 5 years of age
研究者
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