A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children

Study Overview
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Brief Summary
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The primary objective of this study was to determine the effect on immune reactivity to motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524) administered for a second season in children.

Detailed Description
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This was a Phase 1/2, randomized, double-blind study in which motavizumab (MEDI-524) or palivizumab was administered to children who previously participated in MI-CP104. Children who received at least 3 doses of motavizumab in MI-CP104 were eligible for enrollment. Subjects were randomized 1:1 to receive motavizumab or palivizumab at 15 mg/kg by IM injection every 30 days for a total of 4-5 injections during the 2004-05 RSV season subsequent to the season in which they were participants of MI-CP104. All subjects were evaluated prior to and 30 minutes after each injection of study drug with 2 follow-up evaluations, one at 30 days and the other at 90-120 days after the last dose.

Official Title
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A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), After Dosing for a Second Season in Children Who Previously Received MEDI-524 in Protocol MI-CP104

Conditions
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Motavizumab Administration for a Second Season for RSV Prophylaxis

Intervention / Treatment
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* Biological: motavizumab (MEDI-524)
* Biological: palivizumab 15 mg/kg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous participation in MI-CP104 and received at least 3 injections of MEDI-524 in MI-CP104 The child must be less than or equal to 24 months of age at time of entry into the study (child must be entered on or before their 24-month birthday) The child must be able to complete the follow-up visits through 3-4 months after last dose (total length of participation of 6-8 months) Written informed consent obtained from the patient's parent(s) or legal guardian Exclusion Criteria: Currently hospitalized Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure [CPAP]) Evidence of infection with hepatitis A, B, or C virus Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection Suspected serious allergic or immune mediated events with prior receipt of MEDI-524 Acute illness or progressive clinical disorder Active infection, including acute respiratory syncytial virus (RSV) infection at the time of enrollment Previous reaction to IGIV, blood products, or other foreign proteins Have ever received palivizumab Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV [RespiGam(R)], IVIG), or any investigational agents (except MEDI-524) Currently participating in any investigational study

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: motavizumab (MEDI-524) 15 mg/kg<br>A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled. | Biological: motavizumab (MEDI-524)<br>* Patients will receive 15 mg/kg MEDI-524 administered IM every 30 days for a total of 4-5 injections.<br>* Other names: Rezield;|
| Active Comparator: palivizumab 15 mg/kg<br>A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled. | Biological: palivizumab 15 mg/kg<br>* Patients will receive 15 mg/kg palivizumab administered IM every 30 days for a total of 4-5 injections.<br>* Other names: synagis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Exhibiting Anti-motavizumab Antibodies | Serum for measurement of anti-motavizumab antibodies was collected prior to the first, second and, if applicable, fifth doses of study drug, and at the 2 follow-up visits 30 and 90-120 days post final dose. | Day 0 through 120 days post final dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Reporting Adverse Events (AEs) | Assessments of adverse events (including SAEs) were made by clinical investigators according to the protocol. | Day 0 through 30 days post final dose | 
| Number of Subjects Reporting Serious Adverse Events (SAEs) | Assessments of SAEs were made by clinical investigators according to the protocol. | Day 0 through 30 days post final dose | 
| Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations | Serum chemistry and hematology parameters were measured at baseline, on Days 25-30 and 120, 30 days post the final dose, and at premature discontinuation. | Day 0 through 30 days post final dose | 
| Motavizumab Serum Concentrations at Each Data Collection Visit | Mean serum concentration. | Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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motavizumab, palivizumab, synagis, Rezield, MEDI-524