A Phase 3 Study of MEDI-524 (Motavizumab), an Enhanced Potency Humanized Respiratory Syncytial Virus (RSV) Monoclonal Antibody, for the Prevention of RSV Disease Among Native American Infants in the Southwestern United States
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,127
- 试验地点
- 12
- 主要终点
- Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization
研究概览
简要总结
MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American Infants in the Southwestern United States during their first RSV season.
详细描述
MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American infants during their first RSV season.
Participants were randomized in a 2:1 ratio to receive either 15 mg/kg motavizumab or placebo by intramuscular (IM) injection every 30 days during the RSV season for a maximum of 5 injections.
During their first RSV season, participants were evaluated monthly just prior to each injection of study drug for adverse events (AEs) (including medically attended otitis media), with a final post-dosing follow up evaluation at Study Day 150. During Seasons 1, 2, and 3, blood was to be collected prior to the first and last dose of study drug for serum chemistry evaluations, motavizumab serum concentrations, and anti-motavizumab antibodies. Efficacy and safety outcomes were examined through Study Day 150 and wheezing outcomes were evaluated from the time of randomization until the third birthday.
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
- 0 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
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 participant's parent(s) or legal guardian
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 (CHD) (children with uncomplicated CHD [e.g., Patent ductus arteriosus, small septal defect] and children with complicated CHD who are currently anatomically and hemodynamically)
- •Known immunodeficiency
- •Mother with human immunodeficiency virus infection (unless the child has been proven to be not infected)
- •Known allergy to Ig products
- •Receipt of palivizumab, Respiratory syncytial virus immunoglobulin, intravenous (RSV-IGIV), or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B immunoglobulin, 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
结局指标
主要结局
Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization
时间窗: From study Day 0 through study Day 150
An RSV hospitalization is defined as either 1) a respiratory hospitalization with a positive central real-time reverse transcription polymerase chain reaction (RT-PCR) RSV test collected within 3 days of hospitalization or 2) new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test.
次要结局
- Mean Trough Serum Concentrations of Motavizumab(Day 0 (pre Dose 1) and Day 120 (Pre Dose 5))
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)(From study Day 0 through study Day 150)
- Number of Participants With RSV Outpatient Medically Attended Lower Respiratory Illness (MA LRI)(From study Day 0 through study Day 150)
- Number of Participants With Frequency of MA-OM Events(From study Day 0 through study Day 150)
- Number of Participants With Positive Anti-Motavizumab Antibodies After Any Dose(Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5))
- Number of Participants With Frequency of Medically Attended Wheezing Events(Study Day 0 through 3 years)
- Number of Participants With Positive Anti-Motavizumab Antibodies After Full Dose(Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5))
- Number of Participants With Serious Early Childhood Wheezing Episodes(From first year through 3 years)
- Number of Participants With Medically Attended-Otitis Media (MA-OM) Events(From study Day 0 through study Day 150)
- Number of Participants With Medically Attended Wheezing Episodes(From first year through 3 years)