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) (MELODY)

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ClinicalTrials.gov Identifier: NCT03979313

Recruitment Status : Completed

First Posted : June 7, 2019

Results First Posted : February 28, 2024

Last Update Posted : February 28, 2024

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

Tracking Information

First Submitted Date ^ICMJE

May 30, 2019

First Posted Date ^ICMJE

June 7, 2019

Results First Submitted Date ^ICMJE

August 21, 2023

Results First Posted Date ^ICMJE

February 28, 2024

Last Update Posted Date

February 28, 2024

Actual Study Start Date ^ICMJE

July 23, 2019

Actual Primary Completion Date

March 11, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort) [ Time Frame: Through 150 Days Post Dose ]

Primary Endpoint Analysed on Primary Cohort Through 150 Days (N=1490 Participants)

Original Primary Outcome Measures ^ICMJE

Incidence of medically attended LRTI due to RT-PCR confirmed RSV [ Time Frame: 150 days post dose ]

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.

Change History

Current Secondary Outcome Measures ^ICMJE

Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort) [ Time Frame: 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 [ Time Frame: By visit until day 360 post dose ]
Number of Subjects with at Least one Assessment
Anti-drug Antibody Results by Visit (As Treated Population) [ Time Frame: From baseline to 360 day post dose visit ]
Number of subjects with a positive result and a valid titer result at the specific visit

Original Secondary Outcome Measures ^ICMJE

Incidence of hospitalization due to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) confirmed RSV [ Time Frame: 150 days post dose ]
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.
Safety and tolerability of MEDI8897 as assessed by the occurrence of all treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE) [ Time Frame: 360 days post dose ]
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).
Single-dose serum concentrations of MEDI8897 [ Time Frame: 360 days post dose ]
MEDI8897 serum concentration levels will be assessed by mean serum concentration of MEDI8897 at pre-specified timepoints and tabulated by treatment group.
Incidence of anti-drug antibody (ADA) to MEDI8897 in serum [ Time Frame: 360 days post dose ]
The incidence of ADA to MEDI8897 will be assessed and summarized by percentage of subjects that are ADA positive by treatment group.

Current Other Pre-specified Outcome Measures

Number of Participants With MA RSV LRTI Through 150 Days Post Dose (All Subjects) [ Time Frame: Through 150 Days Post Dose ]
Primary Endpoint Analysed on All Subjects Through 150 Days (N=3012 participants)
Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (All Subjects) [ Time Frame: Through 150 Days Post Dose ]
Hospitalization Analysed on All Subjects Through 150 Days (N=3012 participants)
Number of Participants With Disease From the 2nd RSV Season (All Subjects) [ Time Frame: From Day 361 to Day 510 Post Dose ]

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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)

Official Title ^ICMJE

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)

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 Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Respiratory Syncytial Virus Infections

Intervention ^ICMJE

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

Study Arms ^ICMJE

Experimental: MEDI8897
Anti-RSV monoclonal antibody with an extended half-life

Intervention: Drug: MEDI8897
Placebo Comparator: Placebo
Commercially available 0.9% (w/v) saline

Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

3012

Original Estimated Enrollment ^ICMJE

3000

Actual Study Completion Date ^ICMJE

March 21, 2023

Actual Primary Completion Date

March 11, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

0 Years to 1 Year (Child)

Accepts Healthy Volunteers ^ICMJE

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Czechia, Estonia, Finland, France, Germany, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, New Zealand, Panama, Poland, Russian Federation, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States

Removed Location Countries

Brazil, Hungary

Administrative Information

NCT Number ^ICMJE

NCT03979313

Other Study ID Numbers ^ICMJE

D5290C00004
2019-000114-11 ( EudraCT Number )

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:	Yes
Plan Description:	Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting Materials:	Study Protocol
Supporting Materials:	Statistical Analysis Plan (SAP)
Time Frame:	AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria:	When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL:	https://astrazenecagroup-dt.pharmacm.com/DT/Home