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
- 291
- 主要终点
- Participants with solicited daily body temperature with fever 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)
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.
- •Is available to complete the follow-up period.
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.
研究组 & 干预措施
Clesrovimab
Participants will receive intramuscular (IM) injections of clesrovimab and placebo
干预措施: Clesrovimab (Biological)
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: Placebo (Biological)
结局指标
主要结局
Participants with solicited daily body temperature with fever in RSV Season 1
时间窗: Up to 5 days
Percentage of participants with solicited daily body temperature with fever in RSV Season 1
Participants with non-serious AEs in RSV Season 1
时间窗: Up to 42 days
Percentage of participants with non-serious AEs in RSV Season 1
Participants with serious AEs (SAEs) through the duration of participation in RSV Season 1
时间窗: Up to 365 days
Percentage of participants with serious AEs (SAEs) through the duration of participation in RSV Season 1
Participants with anaphylaxis/hypersensitivity AEs of special interest (AESI) in RSV Season 1
时间窗: Up to 42 days
Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1
Participants with rash AESI in RSV Season 1
时间窗: Up to 42 days
Percentage of participants with rash AESI in RSV Season 1
Participants with solicited injection-site Adverse Events (AEs) in RSV Season 1
时间窗: Up to 5 days
Percentage of participants with solicited injection-site AEs in RSV Season 1
Participants with solicited systemic AEs in RSV Season 1
时间窗: Up to 5 days
Percentage of participants with solicited systemic AEs in RSV Season 1
次要结局
- Participants with RSV-associated hospitalization in RSV Season 1(Up to 150 days)
- Participants with anaphylaxis/hypersensitivity AESI in RSV Season 2(From approximately 393 days up to 440 days)
- Participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1(Up to 150 days)
- Participants with solicited systemic AEs in RSV Season 2(From approximately 393 days up to 400 days)
- Participants with rash AESI in RSV Season 2(From approximately 393 days up to 440 days)
- Participants with non-serious AEs in RSV Season 2(From approximately 393 days up to 440 days)
- Concentration of clesrovimab in RSV Season 1(Up to 240 days)
- Participants with SAEs in RSV Season 2(From approximately 393 days up to 575 days)
- Concentration of clesrovimab in RSV Season 2(From approximately 393 days up to 550 days)
- Participants with solicited injection-site AEs in RSV Season 2(From approximately 393 days up to 400 days)
- Participants with solicited daily body temperature with fever in RSV Season 2(From approximately 393 days up to 400 days)