CTIS2022-500350-42-01进行中（未招募）1 期
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 - MK-1654-004
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
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 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 MK-1654, 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
研究者
相似试验
进行中（未招募）
1 期
A study to test the safety of MK-1654 and how well MK-1654 works in healthy infants.EUCTR2020-002405-26-Outside-EU/EEAMerck Sharp & Dohme LLC
进行中（未招募）
1 期
A study to test the safety of MK-1654 and how well MK-1654 works in healthy infants.Prevention of RSVMedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 21.1Level: LLTClassification code 10066742Term: Respiratory syncytial virus infection prophylaxisSystem Organ Class: 100000004865EUCTR2020-002405-26-ITMERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.3,300
进行中（未招募）
1 期
A study to test the safety of MK-1654 and how well MK-1654 works in healthy infants.Prevention of RSVMedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 21.1Level: LLTClassification code 10066742Term: Respiratory syncytial virus infection prophylaxisSystem Organ Class: 100000004865EUCTR2020-002405-26-BEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.3,300
招募中
1 期
A study to test the safety of MK-1654 and how well MK-1654 works in healthy infants.EUCTR2020-002405-26-FRMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.3,300
进行中（未招募）
2 期
Efficacy and Safety of MK-1654 in Healthy Pre-term and Full-Term InfantsRespiratory syncytial virus infectionJPRN-jRCT2051210019Tanaka Yoshiyuki3,300