A Phase 3 Trial of the Effect of Motavizumab Prophylaxis on Reduction of Serious Early Childhood Wheezing in Infants

Study Overview
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Brief Summary
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The primary objective of this study is to assess the efficacy of motavizumab compared to placebo when administered monthly to preterm infants during their first RSV season for the reduction of the incidence of serious early childhood wheezing from their 2nd through 3rd birthdays.

Detailed Description
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The primary objective of this study is assess the efficacy of motavizumab compared to placebo when administered monthly by intramuscular (IM) injection during the first RSV season for the reduction of the incidence of serious early childhood wheezing in preterm infants between their 2nd and 3rd birthdays.

Official Title
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Motavizumab Prophylaxis on Reduction of the Incidence of Serious Early Childhood Wheezing in Preterm Infants

Conditions
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Wheezing

Intervention / Treatment
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* Biological: Motavizumab
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female infants born at 32 & 1/7 - 35 & 0/7 weeks GA, determined according to available medical records Chronological age of <6 months of age at randomization In good health, in the opinion of the investigator Not more than one of the following AAP-defined risk factors: Childcare attendance School-aged siblings Exposure to environmental air pollutants (not including passive exposure to tobacco smoke) Ability and willingness of the subject's parent/legal guardian to complete all protocol-mandated follow-up telephone contacts, visits and procedures Written informed consent obtained from the subject's parent(s) or legal guardian Exclusion Criteria: Diagnosis of CLD of prematurity (also referred to as BPD) or other chronic pulmonary diseases Diagnosis of hemodynamically significant CHD, defined as requiring medication or supplemental oxygen for their CHD Congenital abnormalities of the airways Severe neuromuscular disease, as determined by the investigator Previous or concurrent treatment with palivizumab or intravenous immunoglobulin (IVIG) Eligible for prophylaxis based on local medical standards and guidelines at participating sites Known immunodeficiency Previous or current diagnosis of an upper or lower respiratory infection by a medical professional Previous or current diagnosis of wheezing, asthma, or other wheezing-related diagnoses Hospitalization at the time of enrollment (in case admitted to nursery as part of routine care, infant should only be randomized immediately prior to being discharged) Any illness or condition that would preclude long-term survival Participation in a trial or an investigational agent for RSV prophylaxis or therapy Inability to be followed through their 3rd birthday

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Motavizumab | Biological: Motavizumab<br>* 15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections<br>* Other names: MEDI-524;|
| Placebo Comparator: 2<br>Placebo | Other: Placebo<br>* 15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of serious early childhood wheezing episodes |  | Between 2nd and 3rd birthdays | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of medically-attended lower respiratory tract wheezing events |  | During 2nd and 3rd birthday | 
| Frequency of medically-attended lower respiratory tract wheezing events from randomization through 3 years of age |  | From randomization through 3 yrs. | 
| Incidence of serious RSV disease |  | Through Day 150 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Good health