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)

Phase 3

Completed

• Conditions: Respiratory Syncytial Virus Infections
• Interventions: Drug: MEDI8897; Drug: Placebo

• Registration Number: NCT03979313
• Lead Sponsor: AstraZeneca

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-05-30
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Study Start: 2019-07-23
• Primary Completion: 2021-03-11
• Disposition First Submitted: 2022-02-03
• Study Completion: 2023-03-21
• Results First Submitted: 2023-08-21
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-05
• Last Update Submitted: 2024-02-05
• Results First Posted: 2024-02-28
• Disposition First Posted: 2024-02-28
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3012

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEDI8897	MEDI8897	Anti-RSV monoclonal antibody with an extended half-life
Placebo	Placebo	Commercially available 0.9% (w/v) saline

Primary Outcome Measures

Name	Time	Method
Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort)	Through 150 Days Post Dose	Primary Endpoint Analysed on Primary Cohort Through 150 Days (N=1490 Participants)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort)	Through 150 Days Post Dose	Hospitalization Analysed on Primary Cohort Through 150 Days (N=1490 Participants)
Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group	By visit until day 360 post dose	Number of Subjects with at Least one Assessment
Anti-drug Antibody Results by Visit (As Treated Population)	From baseline to 360 day post dose visit	Number of subjects with a positive result and a valid titer result at the specific visit

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom