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)

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)

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Drug: MEDI8897; Drug: Placebo

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: Interventional
• Enrollment (Actual): 3012
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • San Miguel de Tucuman, Argentina, 4000
    • Research Site
  • San Miguel de Tucuman, Argentina, T4000NWB
    • Research Site
• Australia
  • Clayton, Australia, 3168
    • Research Site
  • Nedlands, Australia, 6009
    • Research Site
• Austria
  • Graz, Austria, 8036
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  • Vienna, Austria, 1090
    • Research Site
• Belgium
  • Brugge, Belgium, 8000
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  • Brussels, Belgium, 1090
    • Research Site
  • Brussels, Belgium, 1070
    • Research Site
  • Bruxelles, Belgium, 1000
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  • Gent, Belgium, 9000
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• Bulgaria
  • Montana, Bulgaria, 3400
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  • Pazardzhik, Bulgaria, 4400
    • Research Site
  • Pleven, Bulgaria, 5800
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  • Plovdiv, Bulgaria, 4000
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  • Plovdiv, Bulgaria, 4002
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  • Ruse, Bulgaria, 7002
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  • Sofia, Bulgaria, 1407
    • Research Site
  • Veliko Tarnovo, Bulgaria, 5000
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• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • Research Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • Research Site
  • Quebec
    • Pierrefonds, Quebec, Canada, H9H 4Y6
      • Research Site
• Chile
  • Santiago, Chile, 8880465
    • Research Site
• Colombia
  • Cali, Colombia
    • Research Site
  • Chia, Colombia, 250002
    • Research Site
  • Medellin, Colombia, 50036
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  • Medellin, Colombia, 500515
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  • Monteria, Colombia, 230002
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  • Soledad, Colombia, 083001
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• Czechia
  • Havlickuv Brod, Czechia, 580 22
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• Estonia
  • Paide, Estonia, 72713
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  • Tallinn, Estonia, 10617
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  • Tallinn, Estonia, 13419
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  • Tallinn, Estonia, 10117
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  • Tartu, Estonia, 50406
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• Finland
  • Espoo, Finland, 02230
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  • Helsinki, Finland, 00100
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  • Jarvenpaa, Finland, 04400
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  • Kokkola, Finland, 67100
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  • Oulu, Finland, 90220
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  • Pori, Finland, 28100
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  • Seinäjoki, Finland, 60100
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  • Tampere, Finland, 33100
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  • Turku, Finland, 20520
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• France
  • Amiens Cedex 1, France, 80054
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  • Bordeaux, France, 33000
    • Research Site
  • Brest, France, 29609
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  • Bron, France, 69677
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  • Caen, France, 14033
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  • Creteil Cedex, France, 94010
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  • Lille, France, 59020
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• Germany
  • Frankenthal, Germany, 67227
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  • Leipzig, Germany, 04103
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  • Mannheim, Germany, 68161
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• Israel
  • Beer-Sheva, Israel, 84001
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  • Netanya, Israel, 4244916
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• Italy
  • Roma, Italy, 00137
    • Research Site
• Japan
  • Fukuyama-shi, Japan, 721-8511
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  • Kawasaki-shi, Japan, 210-0013
    • Research Site
  • Maebashi-shi, Japan, 371-0811
    • Research Site
  • Okayama-shi, Japan, 701-1192
    • Research Site
  • Osaka-shi, Japan, 556-0005
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  • Sapporo-shi, Japan, 062-0931
    • Research Site
  • Shizuoka-shi, Japan, 420-0005
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  • Yokosuka-shi, Japan, 238-8558
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• Korea, Republic of
  • Incheon, Korea, Republic of, 22332
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  • Seoul, Korea, Republic of, 03722
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• Latvia
  • Jekabpils, Latvia, LV-5201
    • Research Site
  • Riga, Latvia, 1004
    • Research Site
  • Riga, Latvia, LV1002
    • Research Site
  • Valmiera, Latvia, 4200
    • Research Site
  • Valmiera, Latvia, LV-4201
    • Research Site
• Lithuania
  • Kaunas, Lithuania, 48259
    • Research Site
  • Kaunas, Lithuania, 50161
    • Research Site
• Mexico
  • Mexico, Mexico, 06720
    • Research Site
• New Zealand
  • Christchurch, New Zealand, 8011
    • Research Site
  • Grafton, New Zealand, 1023
    • Research Site
  • Papatoetoe, New Zealand, 2025
    • Research Site
  • Wellington, New Zealand, 6021
    • Research Site
• Panama
  • Chorrera, Panama
    • Research Site
  • Cuidad De Panama, Panama
    • Research Site
  • David, Panama
    • Research Site
  • Panama, Panama
    • Research Site
  • Panama City, Panama
    • Research Site
• Poland
  • Krakow, Poland, 30-363
    • Research Site
  • Kraków, Poland, 30-348
    • Research Site
  • Leczna, Poland, 21-010
    • Research Site
  • Toruń, Poland, 87-100
    • Research Site
  • Wroclaw, Poland, 53-149
    • Research Site
  • Wrocław, Poland, 51-169
    • Research Site
• Russian Federation
  • Perm, Russian Federation, 614066
    • Research Site
  • Saint Petersburg, Russian Federation, 191025
    • Research Site
  • St Petersburg, Russian Federation, 193312
    • Research Site
  • St Petersburg, Russian Federation, 196084
    • Research Site
• South Africa
  • Cape Town, South Africa, 7505
    • Research Site
  • Cape Town, South Africa, 7800
    • Research Site
  • Cape Town, South Africa, 7530
    • Research Site
  • Durban, South Africa, 4091
    • Research Site
  • Johannesburg, South Africa, 2193
    • Research Site
  • Johannesburg, South Africa, 2112
    • Research Site
  • Pretoria, South Africa, 0101
    • Research Site
  • Pretoria, South Africa, 0087
    • Research Site
  • Rondebosch, South Africa, 7700
    • Research Site
  • Soweto, South Africa, 2013
    • Research Site
• Spain
  • Alicante, Spain, 03010
    • Research Site
  • Antequera, Spain, 29200
    • Research Site
  • Castellon de la Plana, Spain, 12004
    • Research Site
  • Cordoba, Spain, 14004
    • Research Site
  • Granada, Spain, 18014
    • Research Site
  • La Laguna, Spain, 38320
    • Research Site
  • Leganes, Spain, 28911
    • Research Site
  • Lleida, Spain, 25198
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Malaga, Spain, 29004
    • Research Site
  • Mostoles, Spain, 28938
    • Research Site
  • Pozuelo de Alarcon, Spain, 28223
    • Research Site
  • San Juan de Alicante, Spain, 03550
    • Research Site
  • Sant Cugat del Valles, Spain, 08190
    • Research Site
  • Santiago de Compostela, Spain, 15706
    • Research Site
  • Valencia, Spain, 46017
    • Research Site
• Sweden
  • Linköping, Sweden, 587 58
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  • Stockholm, Sweden, 118 83
    • Research Site
• Turkey
  • Adana, Turkey, 01330
    • Research Site
  • Ankara, Turkey, 06100
    • Research Site
  • Izmir, Turkey, 35100
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  • Kocaeli, Turkey, 41380
    • Research Site
• Ukraine
  • Chernivtsі, Ukraine, 58001
    • Research Site
  • Dnipro, Ukraine, 49027
    • Research Site
  • Kyiv, Ukraine, 04050
    • Research Site
  • Sumy, Ukraine, 40022
    • Research Site
  • Vinnytsia, Ukraine, 21021
    • Research Site
• United Kingdom
  • Liverpool, United Kingdom, L12 2AP
    • Research Site
  • London, United Kingdom, SW17 0RE
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Research Site
  • Arizona
    • Fort Defiance, Arizona, United States, 86504
      • Research Site
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Research Site
  • California
    • Anaheim, California, United States, 92804
      • Research Site
    • Downey, California, United States, 90240
      • Research Site
    • National City, California, United States, 91950
      • Research Site
    • Paramount, California, United States, 90723
      • Research Site
    • West Covina, California, United States, 91790
      • Research Site
  • Colorado
    • Aurora, Colorado, United States, 80015
      • Research Site
    • Colorado Springs, Colorado, United States, 80922
      • Research Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Research Site
  • Florida
    • Gainesville, Florida, United States, 32653
      • Research Site
    • Hialeah, Florida, United States, 33012
      • Research Site
    • Miami, Florida, United States, 33142
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Research Site
    • Fort Gordon, Georgia, United States, 30905
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Research Site
    • Oak Lawn, Illinois, United States, 60453
      • Research Site
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Research Site
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Research Site
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Research Site
    • Lexington, Kentucky, United States, 40517
      • Research Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Research Site
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Research Site
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Research Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68504
      • Research Site
    • Omaha, Nebraska, United States, 68114
      • Research Site
  • New Mexico
    • Gallup, New Mexico, United States, 87301
      • Research Site
    • Shiprock, New Mexico, United States, 87420
      • Research Site
  • New York
    • Syracuse, New York, United States, 13210
      • Research Site
  • North Carolina
    • Boone, North Carolina, United States, 28607
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Research Site
    • Cleveland, Ohio, United States, 44109
      • Research Site
    • Cleveland, Ohio, United States, 44121
      • Research Site
    • Columbus, Ohio, United States, 43205
      • Research Site
    • Dayton, Ohio, United States, 45406
      • Research Site
    • Dayton, Ohio, United States, 45414
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Research Site
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16506
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • Research Site
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Research Site
  • South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Research Site
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Research Site
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Research Site
    • Memphis, Tennessee, United States, 38103
      • Research Site
    • Tullahoma, Tennessee, United States, 37388
      • Research Site
  • Texas
    • Baytown, Texas, United States, 77521
      • Research Site
    • Dallas, Texas, United States, 75251
      • Research Site
    • Edinburg, Texas, United States, 78539
      • Research Site
    • League City, Texas, United States, 77573
      • Research Site
    • Longview, Texas, United States, 75605
      • Research Site
    • Pearland, Texas, United States, 77584
      • Research Site
    • San Antonio, Texas, United States, 78249
      • Research Site
    • San Antonio, Texas, United States, 78240
      • Research Site
    • Tomball, Texas, United States, 77375
      • Research Site
  • Utah
    • Layton, Utah, United States, 84041
      • Research Site
    • Roy, Utah, United States, 84067
      • Research Site
    • Saint George, Utah, United States, 84790
      • Research Site
    • Salt Lake City, Utah, United States, 84107
      • Research Site
    • Salt Lake City, Utah, United States, 84123
      • Research Site
    • South Jordan, Utah, United States, 84095
      • Research Site
  • Virginia
    • Charlottesville, Virginia, United States, 22902
      • Research Site
    • Richmond, Virginia, United States, 23219
      • Research Site
  • Washington
    • Seattle, Washington, United States, 98105
      • Research Site
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Research Site
  • Wisconsin
    • Marshfield, Wisconsin, United States, 54449
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 year (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort)	Primary Endpoint Analysed on Primary Cohort Through 150 Days (N=1490 Participants)	Through 150 Days Post Dose

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, Zar HJ, Brooks D, Grenham A, Wahlby Hamren U, Mankad VS, Ren P, Takas T, Abram ME, Leach A, Griffin MP, Villafana T; MELODY Study Group. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022 Mar 3;386(9):837-846. doi: 10.1056/NEJMoa2110275.
• Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11. No abstract available.

Helpful Links

• Redacted CSP
• Redacted SAP
• Redacted CSR synopsis

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2019
• Primary Completion (Actual): March 11, 2021
• Study Completion (Actual): March 21, 2023

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: RSV; Lower Respiratory Tract Infection; Respiratory Syncytial Virus; Late Preterm Infants; Healthy Infants
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Infections; Respiratory Tract Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: D5290C00004; 2019-000114-11 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No