A Pivotal Phase 3 Study of MEDI-524 (Numax; Motavizumab), an Enhanced Potency Humanized RSV Monoclonal Antibody, for the Prophylaxis of Serious RSV Disease in High-Risk Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6,635
- 试验地点
- 676
- 主要终点
- Number of Participants Reporting Any Serious Adverse Events (SAEs)
研究概览
简要总结
The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease. A secondary objective was to compare the incidence of medically-attended lower respiratory infections (LRIs) between treatment groups.
详细描述
A randomized, double-blind, palivizumab-controlled, multi-center, multi-national trial conducted during 2 Northern Hemisphere RSV seasons with an intervening season in the Southern Hemisphere. Each child only participated during a single RSV season. Approximately 6,600 children at risk for serious RSV disease were to be randomized in a 1:1 ratio to receive either 15 mg/kg of palivizumab or motavizumab by IM injection every 30 days for a total of 5 doses.
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
- •24 months of age or younger at randomization (child must be randomized on or before his/her 24-month birthday) with a diagnosis of chronic lung disease (CLD) of prematurity requiring medical intervention/management (i.e., supplemental oxygen, bronchodilators, or diuretics) within 6 months before randomization
- •35 weeks gestational age or less at birth and 6 months of age or younger at randomization (children were to be randomized on or before his/her 6-month birthday)
排除标准
- •Hospitalization at the time of randomization (unless discharge was anticipated within 10 days)
- •Mechanical ventilation or other mechanical support (including continuous positive airways pressure [CPAP])
- •Life expectancy < 6 months
- •Active RSV infection (a child with signs/symptoms of respiratory infection must have had negative RSV testing)
- •Known renal impairment
- •Known hepatic dysfunction
- •Chronic seizure or evolving or unstable neurologic disorder
- •Congenital heart disease [CHD] (children with uncomplicated CHD [e.g., patent ductus arterious (PDA), small septal defect] and children with complicated CHD that were currently anatomically and hemodynamically normal could be enrolled)
- •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, VZIG) 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
研究组 & 干预措施
motavizumab (MEDI-524)
15 mg/kg of motavizumab was administered intramuscularly for 5 monthly doses
干预措施: motavizumab (MEDI-524) (Biological)
结局指标
主要结局
Number of Participants Reporting Any Serious Adverse Events (SAEs)
时间窗: Days 0 - 150
Number of participants reporting one or more SAEs
Number of Participants Reporting Changes in Vital Signs From Baseline
时间窗: Days 0 - 150
Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs
Number of Participants Who Discontinued Study Drug Due to AEs
时间窗: Days 0 - 150
Number of Participants Reporting Any Adverse Events (AEs)
时间窗: Days 0 - 150
Number of participants reporting one or more AEs
Number of Participants Reporting Any Related SAEs
时间窗: Days 0 - 150
Number of participants reporting one or more SAEs considered related to study drug by the investigator
Incidence of RSV Hospitalization (Includes Deaths by RSV)
时间窗: Days 0 - 150
RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence).
Number of Participants Reporting Any Related AEs
时间窗: Days 0 - 150
Number of participants reporting one or more AEs considered related to study drug by the investigator
Number of Participants Reporting AEs by Highest Severity Grade
时间窗: Days 0 - 150
Adverse events events were graded by severity; Level 1, 2, 3, or 4
Number of Participants Who Died
时间窗: Days 0 - 150
次要结局
- The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI)(Day 0 - 150)
- The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2(30 days post Dose 2)
- The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4(30 days post Dose 4)
- The Number of Participants With Anti-motavizumab Antibodies(Day 0 - 120)
- The Incidence of Medically-attended Otitis Media (OM) Infections(Days 0 - 150)
- The Frequency of Prescribed Antibiotics for Medically-attended LRI(Days 0 - 150)
- The Frequency of Prescribed Antibiotics for Medically-attended OM Infections(Days 0 - 150)
- The Serum Concentrations of Motavizumab at Day 0(Day 0)
- The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups(Days 0 - 150)
- The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1(30 days post Dose 1)
- The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3(30 days post Dose 3)