A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.

Detailed Description
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This pivotal Phase 3 study will determine if MEDI8897 will prevent medically attended RSV-confirmed lower respiratory tract infections (LRTI) in healthy infants entering their first RSV season. The population to be enrolled is healthy late preterm and term infants born 35 weeks 0 days or greater gestational age (GA) who would not be eligible to receive RSV prophylaxis. A total of approximately 3,000 infants will be randomized 2:1 to receive either MEDI8897 or placebo. All subjects will be followed for approximately 510 days after dosing. Enrollment is planned at approximately 350 sites across the USA, Canada, Europe, Asia, and Southern Hemisphere.

Official Title
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A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)

Conditions
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Respiratory Syncytial Virus Infections

Intervention / Treatment
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* Drug: MEDI8897
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Healthy infants in their first year of life and born at or after 35 weeks 0 days GA Infants who are entering their first RSV season at the time of screening Key Exclusion Criteria: Meets national or other local criteria to receive commercial palivizumab Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days prior to randomization Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 1 Year

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEDI8897<br>Anti-RSV monoclonal antibody with an extended half-life | Drug: MEDI8897<br>* Anti-RSV monoclonal antibody with an extended half-life<br>|
| Placebo Comparator: Placebo<br>Commercially available 0.9% (w/v) saline | Drug: Placebo<br>* Commercially available 0.9% (w/v) saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of medically attended LRTI due to RT-PCR confirmed RSV | The incidence of RSV LRTI (inpatient and outpatient) 150 days post dose will be based on RSV test results (performed centrally via RT-PCR) and objective clinical LRTI criteria and will be presented by treatment group. The relative risk reduction of MEDI8897 over placebo in preventing RSV LRTI will be estimated from model. | 150 days post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hospitalization due to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) confirmed RSV | The incidence of RSV hospitalization 150 days post dose will be presented by treatment group. The relative risk reduction of MEDI8897 over placebo in preventing RSV hospitalization will be estimated from model. | 150 days post dose | 
| Safety and tolerability of MEDI8897 as assessed by the occurrence of all treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE) | Safety of MEDI8897 will primarily be assessed and measured by the occurrence of all treatment-emergent AEs and SAEs. Other safety assessments will include the occurrence of Adverse Event of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs). | 360 days post dose | 
| Single-dose serum concentrations of MEDI8897 | MEDI8897 serum concentration levels will be assessed by mean serum concentration of MEDI8897 at pre-specified timepoints and tabulated by treatment group. | 360 days post dose | 
| Incidence of anti-drug antibody (ADA) to MEDI8897 in serum | The incidence of ADA to MEDI8897 will be assessed and summarized by percentage of subjects that are ADA positive by treatment group. | 360 days post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RSV, Respiratory Syncytial Virus, Late Preterm Infants, Healthy Infants, Lower Respiratory Tract Infection