Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)

The approved liquid formulation of palivizumab was developed to simplify preparation of the drug before injection. Both formulations of palivizumab have been shown to be bioequivalent in children 6 months of age or younger with a history of chronic lung disease. In previous studies of liquid palivizumab, immunogenicity was evaluated up to 2 months after dosing in adults, and 1 month after dosing in children. In this study, MI-CP116, immunogenicity will be evaluated between 4 and 6 months after the last dose of study drug, in order to provide data at a time point significantly distant from dosing when drug interference is minimal.

Inclusion criteria

• Medically stable child with chronic lung disease of prematurity who is ≤24 months of age at randomization OR child with premature birth (gestational age ≤35 weeks or less) and who is 6 months of age or younger at randomization
• Written informed consent obtained from the patient's parent(s) or legal guardian(s)
• The child must be able to complete the follow-up visit 4-6 months after the last dose of study drug

Exclusion criteria

• Hospitalization at the time of randomization (unless discharge is anticipated within 3 weeks)
• Be receiving mechanical ventilation at the time of study entry (including CPAP)
• Congenital heart disease (children with uncomplicated CHD [e.g., PDA, small septal defect] and children with complicated CHD who are currently anatomically and hemodynamically normal can be enrolled).
• Mother with HIV infection (unless the child has been proven to be not infected)
• Life expectancy <6 months
• Known allergy to Ig products
• Acute respiratory or other acute infection or illness
• Previous reaction to IGIV, blood products, or other foreign proteins
• Receipt of lyophilized palivizumab, RSV-IG IV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
• Any previous receipt of MEDI-524
• Participation in other investigational drug product studies