A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), After Dosing for a Second Season in Children Who Previously Received MEDI-524 in Protocol MI-CP104
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 8
- 主要终点
- Number of Subjects Exhibiting Anti-motavizumab Antibodies
研究概览
简要总结
The primary objective of this study was to determine the effect on immune reactivity to motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524) administered for a second season in children.
详细描述
This was a Phase 1/2, randomized, double-blind study in which motavizumab (MEDI-524) or palivizumab was administered to children who previously participated in MI-CP104. Children who received at least 3 doses of motavizumab in MI-CP104 were eligible for enrollment. Subjects were randomized 1:1 to receive motavizumab or palivizumab at 15 mg/kg by IM injection every 30 days for a total of 4-5 injections during the 2004-05 RSV season subsequent to the season in which they were participants of MI-CP104. All subjects were evaluated prior to and 30 minutes after each injection of study drug with 2 follow-up evaluations, one at 30 days and the other at 90-120 days after the last dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Previous participation in MI-CP104 and received at least 3 injections of MEDI-524 in MI-CP104
- •The child must be less than or equal to 24 months of age at time of entry into the study (child must be entered on or before their 24-month birthday)
- •The child must be able to complete the follow-up visits through 3-4 months after last dose (total length of participation of 6-8 months)
- •Written informed consent obtained from the patient's parent(s) or legal guardian
排除标准
- •Currently hospitalized
- •Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure [CPAP])
- •Evidence of infection with hepatitis A, B, or C virus
- •Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection
- •Suspected serious allergic or immune mediated events with prior receipt of MEDI-524
- •Acute illness or progressive clinical disorder
- •Active infection, including acute respiratory syncytial virus (RSV) infection at the time of enrollment
- •Previous reaction to IGIV, blood products, or other foreign proteins
- •Have ever received palivizumab
- •Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV [RespiGam(R)], IVIG), or any investigational agents (except MEDI-524)
- •Currently participating in any investigational study
结局指标
主要结局
Number of Subjects Exhibiting Anti-motavizumab Antibodies
时间窗: Day 0 through 120 days post final dose
Serum for measurement of anti-motavizumab antibodies was collected prior to the first, second and, if applicable, fifth doses of study drug, and at the 2 follow-up visits 30 and 90-120 days post final dose.
次要结局
- Number of Subjects Reporting Adverse Events (AEs)(Day 0 through 30 days post final dose)
- Number of Subjects Reporting Serious Adverse Events (SAEs)(Day 0 through 30 days post final dose)
- Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations(Day 0 through 30 days post final dose)
- Motavizumab Serum Concentrations at Each Data Collection Visit(Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose)