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

Study Overview
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Brief Summary
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The purpose of this study is to measure the rate of anti-palivizumab antibodies (also referred to as immune reactivity or immunogenicity) in subjects receiving either the liquid or lyophilized formulation of palivizumab. This study will compare the number and percentage of subjects with anti-palivizumab antibodies receiving either the liquid or lyophilized formulation of palivizumab.

Detailed Description
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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.

Official Title
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A Phase IV, Randomized, Double-Blind Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis) in Children at High Risk for the Development of Serious RSV Disease

Conditions
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Chronic Lung Disease

Intervention / Treatment
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* Biological: Lyophilized Palivizumab
* Biological: Liquid Palivizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Liquid Palivizumab | Biological: Liquid Palivizumab<br>* Patients will receive 15 mg/kg of liquid palivizumab administered intramuscularly every 30 days for a total of 5 injections.<br>* Other names: Synagis;|
| Active Comparator: 2<br>Lyophilized Palivizumab | Biological: Lyophilized Palivizumab<br>* Patients will receive 15 mg/kg of lyophilized palivizumab administered intramuscularly every 30 days for a total of 5 injections.<br>* Other names: Synagis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Percentage of Participants With Immune Reactivity | Presence of anti-palivizumab antibodies | Day 240-300 follow up |