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Keep this study
Lead
MedImmune LLC
The primary objective was to describe the safety and tolerability of motavizumab when given monthly as prophylaxis against serious RSV infection among children with hemodynamically significant congenital heart disease.
Age
0–2
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
24 months of age or younger at randomization (child must have been randomized on or before their 24-month birthday)
Documented, hemodynamically significant CHD
Unoperated or partially corrected CHD
You may not be if
Unstable cardiac or respiratory status, including cardiac defects so severe that survival was not expected or for which cardiac transplantation was planned or anticipated
Hospitalization, unless discharge was anticipated within 21 days
Anticipated cardiac surgery within two weeks of randomization
Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support
Associated non-cardiac anomalies or end organ dysfunction resulting in anticipated survival of less than six months or unstable abnormalities of end organ function
Acute respiratory illness, or other acute infection or illness Note: children with any respiratory symptoms must have had a negative RSV test prior to randomization
Chronic seizure or evolving or unstable neurologic disorder
Known immunodeficiency
Mother with HIV infection (unless the child had been proven to be not infected)
Known allergy to Ig products
Receipt of any polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
Receipt of palivizumab (Synagis®) within 3 months prior to randomization
Use of investigational agents within the past three months (other than investigational agents commonly used during cardiac surgery or the immediate post-operative period, e.g., nitric oxide)
Current participation in other investigational protocols of drugs or biological agents
Previous participation in MI-CP124 (Season 1)
Clareo Health | A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease
