A Phase 2b Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,453
- 试验地点
- 1
- 主要终点
- Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29 and 35 weeks gestational age (GA) and entering their first Respiratory Syncytial Virus (RSV) season.
详细描述
This pivotal Phase 2b study will determine if MEDI8897 will be efficacious in reducing medically attended RSV-confirmed lower respiratory tract infections (LRTI) in healthy preterm infants entering their first RSV season. The population to be enrolled is healthy preterm infants born between 29 weeks 0 days and 34 weeks 6 days GA who would not receive RSV prophylaxis. A total of 1500 infants will be randomized 2:1 to receive either MEDI8897 or placebo. Participants will be followed for 360 days after dosing. Enrollment is planned at approximately 197 sites across the USA, Canada, Europe, and the Southern Hemisphere.
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 365 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants born between 29 weeks 0 days and 34 weeks 6 days GA.
- •Infants who are entering their first full RSV season at the time of screening.
排除标准
- •Meets American Academy of Pediatrics (AAP) or other local criteria to receive commercial palivizumab.
- •Any fever (>= 100.4°F [>= 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization.
- •Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization.
- •Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection.
- •Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination.
研究组 & 干预措施
Placebo
Participants will receive a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
干预措施: Placebo (Drug)
MEDI8897 50 mg
Participants will receive a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
干预措施: MEDI8897 (Drug)
结局指标
主要结局
Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI)
时间窗: From Day 1 through Day 151
The determination of medically attended RSV LRTI is based on objective clinical LRTI criteria and RSV test results obtained from analyzing the respiratory secretions using a validated RSV real time reverse transcriptase-polymerase chain reaction (RT-PCR) assay for the detection of RSV A or RSV B subtypes. Criteria for LRTI included documented physical exam findings of rhonchi, rales, crackles, or wheeze and any of the following: increased respiratory rate at rest (for age less than (\<) 2 months: greater than or equal to (\>=) 60 breaths/min; 2-6 months: \>= 50 breaths/min; and for \> 6 months - 2 years, \>= 40 breaths/min), or hypoxemia (in room air - oxygen saturation \< 95% at altitudes less than or equal to (\<=) 1800 meters or \< 92% at altitudes \> 1800 meters), or clinical signs of severe respiratory disease or dehydration secondary to inadequate oral intake due to respiratory distress (need for intravenous fluid).
次要结局
- Serum Concentration of MEDI8897(Days 91, 151, and 361)
- Elimination Half-life (t1/2) of MEDI8897(Day 91 through Day 361)
- Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI)(From Day 1 through Day 151)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(From Day 1 through Day 361)
- Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs)(From Day 1 through Day 361)
- Number of Participants With Positive Anti-drug Antibodies to MEDI8897(Days 91, 151, and 361)