A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3,632
- 试验地点
- 217
- 主要终点
- RSV Season 1: Number of Participants With Respiratory Syncytial Virus (RSV)-Associated Medically Attended Lower Respiratory Infection (MALRI)
研究概览
简要总结
The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants. It is hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is a healthy male or female who is an early or moderate pre-term infant (≥29 to 34 weeks and 6 days gestational age) or a late pre-term or full-term infant (≥35 weeks gestational age)
- •For the phase 2b cohort only: Has a chronological age >2 weeks of age up to 1 year and is entering their first respiratory syncytial virus (RSV) season at the time of obtaining documented informed consent.
- •For the phase 3 cohort only: Has a chronological age from birth up to 1 year and is entering their first RSV season at the time of obtaining documented informed consent.
- •For participants in South Korea only: Weighs ≥2 kg
排除标准
- •Is recommended to receive palivizumab per local guidelines or professional society recommendations.
- •Has known hypersensitivity to any component of clesrovimab
- •Has a bleeding disorder contraindicating IM administration
- •Has had a recent illness with rectal temperature ≥100.5°F (≥38.1°C) or axillary temperature ≥100.0°F (≥37.8°C) within 72 hours predose
- •Has received any vaccine or monoclonal antibody for the prevention of RSV
- •Is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time before first dose administration or while participating in this study
研究组 & 干预措施
Clesrovimab 105 mg
Participants receive a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1. An eligible subset of participants from RSV Season 1 will enter RSV season 2.
干预措施: Clesrovimab (Biological)
Placebo
Participants receive a single IM administration of placebo on Day 1. An eligible subset of participants from RSV Season 1 will enter RSV season 2.
干预措施: Placebo (Drug)
结局指标
主要结局
RSV Season 1: Number of Participants With Respiratory Syncytial Virus (RSV)-Associated Medically Attended Lower Respiratory Infection (MALRI)
时间窗: From Day 1 (postdose) to Day 150
Outpatient and inpatient MALRI was defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration due to respiratory symptoms; AND 3) RSV-positive reverse transcriptase polymerase chain reaction (RT-PCR) nasopharyngeal sample. Per protocol, the participants with outpatient and inpatient RSV-associated MALRI were reported together for RSV season 1 participants.
RSV Season 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
时间窗: From Day 1 (postdose) to Day 5
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included redness/erythema, swelling, and pain/tenderness. Per protocol, the percentage of RSV season 1 participants with solicited injection-site AEs were reported.
RSV Season 1: Percentage of Participants With Fever
时间窗: From Day 1 (postdose) to Day 5
Fever was defined as rectal temperature ≥102.2°F (≥39.0°C) or axillary temperature ≥101.7°F (≥38.7°C). Per protocol, the percentage of RSV season 1 participants with fever were reported.
RSV Season 1: Percentage of Participants With Solicited Systemic AEs
时间窗: From Day 1 (postdose) to Day 5
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included irritability, somnolence/drowsiness, and appetite lost. Per protocol, the percentage of RSV season 1 participants with solicited systemic AEs were reported.
RSV Season 1: Percentage of Participants With Anaphylaxis/Hypersensitivity AE of Special Interest (AESI)
时间窗: From Day 1 (postdose) to Day 42
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Anaphylaxis/Hypersensitivity AESI included anaphylaxis, angioedema, bronchospasm, drug hypersensitivity, dyspnea, hypersensitivity, dysphonia, and wheezing. Per protocol, the percentage of RSV season 1 participants with anaphylaxis/hypersensitivity AESI were reported.
RSV Season 1: Percentage of Participants With Rash AESI
时间窗: From Day 1 (postdose) to Day 42
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Rash AESI included acute generalized exanthematous pustulosis, drug eruption, drug reaction with eosinophilia and systemic symptoms, erythema multiforme, generalized rash of exfoliative nature, Stevens-Johnson syndrome, toxic epidermal necrolysis, and urticaria. Per protocol, the percentage of RSV season 1 participants with rash AESI were reported.
RSV Season 1: Percentage of Participants With ≥1 Nonserious AE
时间窗: From Day 1 (postdose) to Day 42
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, the percentage of RSV season 1 participants with ≥1 nonserious AE were reported.
Percentage of Participants With Serious Adverse Events (SAEs)
时间窗: RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
An SAE was any untoward medical occurrence that results in death; is life-threatening; required inpatient hospitalization/prolongs existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical event. Per protocol, the percentage of participants in RSV season 1 and RSV season 2 with SAEs were reported.
次要结局
- RSV Season 1: Number of Participants With RSV-Associated Hospitalization(From Day 1 (postdose) to Day 150)
- RSV Season 1: Number of Participants With RSV-Associated MALRI(From Day 1 (postdose) to Day 180)