EUCTR2020-002405-26-BE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
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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A participant will be eligible for inclusion in the study if the participant:
- •1. Is healthy (based on medical history and physical examination results).
- •2. Is male or female and 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).
- •3. For the Phase 2b cohort only: Has a chronological age >2 weeks of age up to 1 year and is entering the first RSV season at the time that documented informed consent is provided.
- •4. For the Phase 3 cohort only: Has a chronological age from birth up to 1 year and is entering the first RSV season at the time that documented informed consent is provided.
- •5. The participant’s legally acceptable representative provides documented informed consent for the study. The participant’s legally acceptable representative may also provide documented consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 3300
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The participant must be excluded from the study if the participant:
- •1. Is eligible or recommended to receive palivizumab per national or local (eg, state or provincial) guidelines or professional society recommendations.
- •2. Has known hypersensitivity to any component of MK-1654 (refer to the IB for a list of components).
- •3. Has a bleeding disorder contraindicating intramuscular administration.
- •4. Has had a recent illness with rectal temperature =100.5°F (=38.1°C) or axillarytemperature =100.0°F (=37.8°C) within 72 hours predose.
- •5. Has received any vaccine or mAb for the prevention of RSV, including receipt of maternal RSV vaccination during the mother’s pregnancy.
- •6. 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 current study. Participants enrolled in observational studies may be included and will be reviewed on a case-by-case basis for approval by the Sponsor.
- •7. Has enrolled previously in the current study and been discontinued.
- •8. Has a parent/legal guardian/legally acceptable representative who is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.
- •9. Has any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
- •10. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
研究者
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