EUCTR2019-000114-11-GB进行中（未招募）1 期
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,000
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
- •Subjects must meet all of the following criteria:
- •1. Healthy infants in their first year of life and born = 35 weeks 0 days GA (infants who have an underlying illness such as cystic fibrosis or Down syndrome with no other risk factors are eligible)
- •2. Infants who are entering their first RSV season at the time of screening
- •3. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the USA, EU Data Privacy Directive in the EU) obtained from the subject's parent(s)/legal representative prior to performing any protocol-related procedures, including screening evaluations
- •4. Subject's parent(s)/legal representative is able to understand and comply with the requirements of the protocol including follow-up and illness visits as judged by the investigator
- •5. Subject is available to complete the follow-up period, which will be 17 months after receipt of study drug
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 3000
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Any of the following would exclude the subject from participation in the study:
- •1. Meets national or other local criteria to receive commercial palivizumab
- •2. Any fever (= 100.4°F [= 38.0°C], regardless of route) or acute illness within 7 days prior to randomization
- •3. Any history of LRTI or active LRTI prior to, or at the time of, randomization
- •4. Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
- •5. Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt during the study with the exception of: a) multivitamins and iron; b) infrequent use of over-the-counter (OTC) medications for the systemic treatment of common childhood symptoms (eg, pain relievers) that may be permitted according to the judgment of the investigator
- •6. Any current or expected receipt of immunosuppressive agents including steroids (except for the use of topical steroids according to the judgment of the investigator)
- •7. History of receipt of blood, blood products, or immunoglobulin products, or expected receipt through the duration of the study
- •8. Receipt of any investigational drug
- •9. Known renal impairment
- •10. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
- •11. History of CLD/bronchopulmonary dysplasia
- •12. Clinically significant congenital anomaly of the respiratory tract
- •13. Chronic seizure or evolving or unstable neurologic disorder
- •14. CHD, except for children with uncomplicated CHD (eg, patent ductus arteriosus, small septal defect)
- •15. Prior history of a suspected or actual acute life-threatening event
- •16. Known immunodeficiency, including human immunodeficiency virus (HIV)
- •17. Mother with HIV infection (unless the child has been proven to be not infected)
- •18. Any known allergy, including to immunoglobulin products, or history of allergic reaction
- •19. Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination
- •20. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, IV immunoglobulin)
- •21. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- •22. Concurrent enrollment in another interventional study
- •23. Children of employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals
研究者
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