NCT00628303撤回3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Motavizumab Prophylaxis on Reduction of the Incidence of Serious Early Childhood Wheezing in Preterm Infants
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- The incidence of serious early childhood wheezing episodes
研究概览
简要总结
The primary objective of this study is to assess the efficacy of motavizumab compared to placebo when administered monthly to preterm infants during their first RSV season for the reduction of the incidence of serious early childhood wheezing from their 2nd through 3rd birthdays.
详细描述
The primary objective of this study is assess the efficacy of motavizumab compared to placebo when administered monthly by intramuscular (IM) injection during the first RSV season for the reduction of the incidence of serious early childhood wheezing in preterm infants between their 2nd and 3rd birthdays.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female infants born at 32 & 1/7 - 35 & 0/7 weeks GA, determined according to available medical records
- •Chronological age of <6 months of age at randomization
- •In good health, in the opinion of the investigator
- •Not more than one of the following AAP-defined risk factors:
- •Childcare attendance
- •School-aged siblings
- •Exposure to environmental air pollutants (not including passive exposure to tobacco smoke)
- •Ability and willingness of the subject's parent/legal guardian to complete all protocol-mandated follow-up telephone contacts, visits and procedures
- •Written informed consent obtained from the subject's parent(s) or legal guardian
排除标准
- •Diagnosis of CLD of prematurity (also referred to as BPD) or other chronic pulmonary diseases
- •Diagnosis of hemodynamically significant CHD, defined as requiring medication or supplemental oxygen for their CHD
- •Congenital abnormalities of the airways
- •Severe neuromuscular disease, as determined by the investigator
- •Previous or concurrent treatment with palivizumab or intravenous immunoglobulin (IVIG)
- •Eligible for prophylaxis based on local medical standards and guidelines at participating sites
- •Known immunodeficiency
- •Previous or current diagnosis of an upper or lower respiratory infection by a medical professional
- •Previous or current diagnosis of wheezing, asthma, or other wheezing-related diagnoses
- •Hospitalization at the time of enrollment (in case admitted to nursery as part of routine care, infant should only be randomized immediately prior to being discharged)
- •Any illness or condition that would preclude long-term survival
- •Participation in a trial or an investigational agent for RSV prophylaxis or therapy
- •Inability to be followed through their 3rd birthday
研究组 & 干预措施
2
Placebo Comparator
Placebo
干预措施: Placebo (Other)
1
Experimental
Motavizumab
干预措施: Motavizumab (Biological)
结局指标
主要结局
The incidence of serious early childhood wheezing episodes
时间窗: Between 2nd and 3rd birthdays
次要结局
- Frequency of medically-attended lower respiratory tract wheezing events(During 2nd and 3rd birthday)
- Frequency of medically-attended lower respiratory tract wheezing events from randomization through 3 years of age(From randomization through 3 yrs.)
- Incidence of serious RSV disease(Through Day 150)
研究者
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