(Medley)-A Phase 2/3 Randomized Double-blind Palivizumab-controlled Study to Evaluate the Safety of MEDI8897 a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus in High-risk Children (MEDLEY)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Rsv
  • Age: Between 34 - 2 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. For Preterm Cohort: Preterm infants in their first year of life and born = 35 weeks 0 days GA with uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, or aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone
    2. For the CLD/CHD cohort: infants in their first year of life and a diagnosis of CLD or CHD
    3. Infants who are entering their first RSV season at the time of screening
    4. Written informed consent and any locally required authorization 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

You may not be eligible for this study if the following are true:

    1. Subjects who have any fever or acute illness within 7 days prior to randomization
    2. Subjects with any history of LRTI or active LRTI prior to, or at the time of, randomization
    3. Subjects with known history of RSV infection or active RSV infection prior to, or at the time of, randomization
    4. Subjects who was hospitalized at the time of randomization, unless discharge is expected within the 7 days after randomization
    5. Subjects requires mechanical ventilation, extracorporeal membrane oxygenation, CPAP, or other mechanical respiratory or cardiac support at the time of randomization
    6. Subjects who is anticipated cardiac surgery within 2 weeks after randomization
    7. Subjects with anticipated survival of <6 months after randomization
    8. Subjects are receiving any investigational drug
    9. Subjects who have renal impairment or hepatic dysfunctioning
    10. Subjects with clinically significant congential anomaly of the respiratory tract
    11. Subjects with chronic seizure, or evolving or unstable neurologic disorder
    12. Prior history of a suspected or actual acute life-threatening event
    13. Subjects have known immunodeficiency, including human immunodeficiency virus (HIV)
    14. Mothers of subjects with HIV infection
    15. Any known allergy, including to immunoglobulin products, or history of allergic reaction
    16. Concurrent enrollment in another interventional study



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