MEDLEY is a clinical study to research an investigational medicine for babies at high risk for respiratory syncytial virus (RSV) disease. The study is looking to see how safe the investigational medication is and if it works as well as a medication already approved to protect against RSV. The study will include about 1500 babies globally. If you decide to take part, your baby may be in the MEDLEY Study for up to 2 years and may have up to 17 scheduled study visits. Your baby will be monitored throughout the study for respiratory illnesses.More
Inclusion Criteria Subjects must meet all of the following criteria: 1. For the preterm cohort (excluding subjects with CLD or hemodynamically significant CHD): preterm infants in their first year of life and born ≤ 35 weeks 0 days GA eligible to receive palivizumab in accordance with national or local guidelines, including those with: (a) Uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, or (b) Aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone 2. For the CLD/CHD cohort: (a) Subjects with CLD - infants in their first year of life and a diagnosis of CLD of prematurity requiring medical intervention/management (ie, supplemental oxygen, bronchodilators, or diuretics) within the 6 months prior to randomization (b) Subjects with CHD - infants in their first year of life and documented, hemodynamically significant CHD (must be unoperated or partially corrected CHD) Note: Infants with hemodynamically significant acyanotic cardiac lesions must have pulmonary hypertension (≥ 40 mmHg measured pressure in the pulmonary artery) or the need for daily medication to manage CHD 3. Infants who are entering their first RSV season at the time of screening 4. 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(s) prior to performing any protocol-related procedures, including screening evaluations 5. Subject's parent(s)/legal representative(s) able to understand and comply with the requirements of the protocol including follow-up and illness visits as judged by the investigator 6. Subject is available to complete the follow-up period, which will be 1 year after Season 1/Dose 1 for subjects without CLD/CHD, or 1 year after Season 2/Dose 1 (or last replacement dose as applicable for CHD) for subjects with CLD/CHD
Detailed Eligibility: Exclusion Criteria Any of the following would exclude the subject from participation in the study: 1. Any fever (≥ 100.4?F [≥ 38.0?C], regardless of route) or acute illness within 7 days prior to randomization 2. Any history of LRTI or active LRTI prior to, or at the time of, randomization 3. Known history of RSV infection or active RSV infection prior to, or at the time of, Randomization 4. Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization 5. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, CPAP, or other mechanical respiratory or cardiac support at the time of randomization 6. Anticipated cardiac surgery within 2 weeks after randomization 7. Anticipated survival of < 6 months after randomization 8. Receipt of any investigational drug 9. Known renal impairment 10. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection 11. Clinically significant congenital anomaly of the respiratory tract 12. Chronic seizure, or evolving or unstable neurologic disorder 13. Prior history of a suspected or actual acute life-threatening event 14. Known immunodeficiency, including human immunodeficiency virus (HIV) 15. Mother with HIV infection (unless the child has been proven to be not infected) 16. Any known allergy, including to immunoglobulin products, or history of allergic reaction 17. Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination 18. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study 19. Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results 20. Concurrent enrollment in another interventional study 21. 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
II/III - A combination of phases: (2) Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. and (3) Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
Childrens Hospital Colorado
Eric Simoes, MD
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