A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab- Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,003
- 试验地点
- 267
- 主要终点
- Number of Participants With Solicited Injection-site Adverse Events (AEs) in RSV Season 1
研究概览
简要总结
This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Randomization occurs on Day 1. Part 1 of this study uses a double-blinding technique until Day 60. Part 2 is unblinded conducted as open-label.
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants at increased risk for severe RSV infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations and meet defined criteria for the Early or Moderate Pre-term Group or the chronic lung disease (CLD)/congenital heart disease (CHD) Group.
- •Is available to complete the follow-up period.
- •Additional inclusion criteria for participation in RSV Season 2:
- •RSV Season 2 participants enrolled in the CLD/CHD Group in RSV Season
- •Participants with CHD must also have the following:
- •Hemodynamically significant CHD at the beginning of RSV Season 2, or
- •If the participant has had surgically repaired hemodynamically significant CHD that did not include extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass: 1) continues to require medications to manage CHD, or 2) any additional medical intervention related to their CHD.
- •RSV Season 2 participants enrolled in the Early or Moderate Pre-term Group in RSV Season 1, with the following:
- •Neuromuscular disease or congenital pulmonary anomaly that impairs the ability to clear secretions from the upper airway because of ineffective cough
- •Down Syndrome (trisomy of chromosome 21)
- •Cystic fibrosis with nutritional compromise
- •Native Americans and Alaskan Indians or other indigenous populations at high risk for severe RSV disease
排除标准
- •Requires mechanical ventilation at time of enrollment.
- •Has a life expectancy <6 months.
- •Has known hepatic or renal dysfunction, or chronic seizure disorder.
- •Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
- •Has severe immunodeficiency or is severely immunocompromised.
- •Has known hypersensitivity to any component of clesrovimab or palivizumab.
- •Additional exclusion criteria for participation in RSV Season 2:
- •Had 1) ECMO or 2) surgical intervention during the RSV season for CHD and required cardiopulmonary bypass during the procedure in RSV Season 1.
研究组 & 干预措施
Palivizumab
Participants will receive IM injections.
干预措施: Palivizumab (Biological)
Clesrovimab
Participants will receive intramuscular (IM) injections of clesrovimab and placebo
干预措施: Clesrovimab (Biological)
Clesrovimab
Participants will receive intramuscular (IM) injections of clesrovimab and placebo
干预措施: Placebo (Biological)
结局指标
主要结局
Number of Participants With Solicited Injection-site Adverse Events (AEs) in RSV Season 1
时间窗: Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
An AE is 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 erythema, pain, and swelling. The number of participants with solicited injection-site AEs in RSV Season 1 is reported.
Number of Participants With Solicited Daily Body Temperatures With Fever in RSV Season 1
时间窗: Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
Fever was defined as maximum rectal temperature ≥102.2 °F (39.0 °C) or maximum axillary temperature ≥101.7 °F. The number of participants with solicited daily body temperature of fever in RSV Season 1 is reported.
Number of Participants With Solicited Systemic AEs in RSV Season 1
时间窗: Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
An AE is 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 decreased appetite, irritability, and somnolence. The number of participants with solicited systemic AEs in RSV Season 1 is reported.
Number of Participants With Anaphylaxis/Hypersensitivity AEs of Special Interest (AESI) in RSV Season 1
时间窗: Up to 42 days in RSV Season 1
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. The number of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1 is reported.
Number of Participants With Rash AESI in RSV Season 1
时间窗: Up to 42 days in RSV Season 1
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 urticaria and drug eruption. The number of participants with rash AESI in RSV Season 1 is reported.
Number of Participants With Nonserious AEs in RSV Season 1
时间窗: Up to 42 days in RSV Season 1
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. The number of participants with nonserious AEs in RSV Season 1 is reported.
Number of Participants With Serious AEs (SAEs) Through the Duration of Participation in RSV Season 1
时间窗: Up to 365 days in RSV Season 1
An SAE is any untoward medical occurrence in a clinical study participant that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. The number of participants with SAEs in RSV Season 1 is reported.
次要结局
- Number of Cases of RSV-associated Medically Attended Lower Respiratory Infection (MALRI) in RSV Season 1(Up to 150 days in RSV Season 1)
- Number of Cases of RSV-associated Hospitalization in RSV Season 1(Up to 150 days in RSV Season 1)
- Number of Participants With Solicited Injection-site AEs in RSV Season 2(Up to 5 days postdose in RSV Season 2 (Up to ~400 days))
- Number of Participants With Solicited Daily Body Temperature With Fever in RSV Season 2(Up to 5 days postdose in RSV Season 2 (Up to ~400 days))
- Number of Participants With Solicited Systemic AEs in RSV Season 2(Up to 5 days postdose in RSV Season 2 (Up to ~400 days))
- Concentration of Clesrovimab in RSV Season 2(At Day 7 and Day 150 postdose in RSV Season 2)
- Number of Participants With Anaphylaxis/Hypersensitivity AESI in RSV Season 2(Up to 42 days postdose in RSV Season 2 (Up to ~440 days))
- Number of Participants With Rash AESI in RSV Season 2(Up to 42 days postdose in RSV Season 2 (Up to ~440 days))
- Number of Participants With Nonserious AEs in RSV Season 2(Up to 42 days postdose in RSV Season 2 (Up to ~440 days))
- Number of Participants With SAEs in RSV Season 2(Up 180 days postdose in RSV Season 2 (Up to ~575 days))
- Concentration of Clesrovimab in RSV Season 1(At Day 7, Day 150, and Day 240 in RSV Season 1)