JPRN-jRCT2051210019进行中（未招募）2 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
Tanaka Yoshiyuki0 个研究点目标入组 3,300 人开始时间: 2021年5月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- ot applicable 至 <= 1age old（—）
- 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).
- •-Has a chronological age >2 weeks of age up to 1 year and is entering the first RSV season at the time of obtaining documented informed consent (Phase 2b cohort only).
- •-Has a chronological age from birth up to 1 year and is entering the first RSV season at the time of obtaining documented informed consent (Phase 3 cohort only).
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 intramuscular 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
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