A Phase IV, Randomized, Double-Blind Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis) in Children at High Risk for the Development of Serious RSV Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 417
- 试验地点
- 107
- 主要终点
- Number and Percentage of Participants With Immune Reactivity
研究概览
简要总结
The purpose of this study is to measure the rate of anti-palivizumab antibodies (also referred to as immune reactivity or immunogenicity) in subjects receiving either the liquid or lyophilized formulation of palivizumab. This study will compare the number and percentage of subjects with anti-palivizumab antibodies receiving either the liquid or lyophilized formulation of palivizumab.
详细描述
The approved liquid formulation of palivizumab was developed to simplify preparation of the drug before injection. Both formulations of palivizumab have been shown to be bioequivalent in children 6 months of age or younger with a history of chronic lung disease. In previous studies of liquid palivizumab, immunogenicity was evaluated up to 2 months after dosing in adults, and 1 month after dosing in children. In this study, MI-CP116, immunogenicity will be evaluated between 4 and 6 months after the last dose of study drug, in order to provide data at a time point significantly distant from dosing when drug interference is minimal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically stable child with chronic lung disease of prematurity who is ≤24 months of age at randomization OR child with premature birth (gestational age ≤35 weeks or less) and who is 6 months of age or younger at randomization
- •Written informed consent obtained from the patient's parent(s) or legal guardian(s)
- •The child must be able to complete the follow-up visit 4-6 months after the last dose of study drug
排除标准
- •Hospitalization at the time of randomization (unless discharge is anticipated within 3 weeks)
- •Be receiving mechanical ventilation at the time of study entry (including CPAP)
- •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).
- •Mother with HIV infection (unless the child has been proven to be not infected)
- •Life expectancy <6 months
- •Known allergy to Ig products
- •Acute respiratory or other acute infection or illness
- •Previous reaction to IGIV, blood products, or other foreign proteins
- •Receipt of lyophilized palivizumab, RSV-IG IV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
- •Any previous receipt of MEDI-524
- •Participation in other investigational drug product studies
结局指标
主要结局
Number and Percentage of Participants With Immune Reactivity
时间窗: Day 240-300 follow up
Presence of anti-palivizumab antibodies
次要结局
未报告次要终点