(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:
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Conditions: Rsv
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Age: Between 34 - 2 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- 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
- For the CLD/CHD cohort: infants in their first year of life and a diagnosis of CLD or CHD
- Infants who are entering their first RSV season at the time of screening
- 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
- 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
- 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:
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- Subjects who have any fever or acute illness within 7 days prior to randomization
- Subjects with any history of LRTI or active LRTI prior to, or at the time of, randomization
- Subjects with known history of RSV infection or active RSV infection prior to, or at the time of, randomization
- Subjects who was hospitalized at the time of randomization, unless discharge is expected within the 7 days after randomization
- Subjects requires mechanical ventilation, extracorporeal membrane oxygenation, CPAP, or other mechanical respiratory or cardiac support at the time of randomization
- Subjects who is anticipated cardiac surgery within 2 weeks after randomization
- Subjects with anticipated survival of <6 months after randomization
- Subjects are receiving any investigational drug
- Subjects who have renal impairment or hepatic dysfunctioning
- Subjects with clinically significant congential anomaly of the respiratory tract
- Subjects with chronic seizure, or evolving or unstable neurologic disorder
- Prior history of a suspected or actual acute life-threatening event
- Subjects have known immunodeficiency, including human immunodeficiency virus (HIV)
- Mothers of subjects with HIV infection
- Any known allergy, including to immunoglobulin products, or history of allergic reaction
- Concurrent enrollment in another interventional study
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.