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)
2 other identifiers
interventional
3,012
29 countries
191
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2019
Typical duration for phase_3
191 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2019
CompletedFirst Posted
Study publicly available on registry
June 7, 2019
CompletedStudy Start
First participant enrolled
July 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2023
CompletedResults Posted
Study results publicly available
February 28, 2024
CompletedFebruary 28, 2024
February 1, 2024
1.6 years
May 30, 2019
August 21, 2023
February 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort)
Through 150 Days Post Dose
Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group
By visit until day 360 post dose
Anti-drug Antibody Results by Visit (As Treated Population)
From baseline to 360 day post dose visit
Other Outcomes (3)
Number of Participants With MA RSV LRTI Through 150 Days Post Dose (All Subjects)
Through 150 Days Post Dose
Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (All Subjects)
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
Study Arms (2)
MEDI8897
EXPERIMENTALAnti-RSV monoclonal antibody with an extended half-life
Placebo
PLACEBO COMPARATORCommercially available 0.9% (w/v) saline
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (198)
Research Site
Birmingham, Alabama, 35205, United States
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Fort Defiance, Arizona, 86504, United States
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Fayetteville, Arkansas, 72703, United States
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Anaheim, California, 92804, United States
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Downey, California, 90240, United States
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National City, California, 91950, United States
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Paramount, California, 90723, United States
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West Covina, California, 91790, United States
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Aurora, Colorado, 80015, United States
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Colorado Springs, Colorado, 80922, United States
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Washington D.C., District of Columbia, 20016, United States
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Gainesville, Florida, 32653, United States
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Hialeah, Florida, 33012, United States
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Miami, Florida, 33142, United States
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Atlanta, Georgia, 30322, United States
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Fort Gordon, Georgia, 30905, United States
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Chicago, Illinois, 60611, United States
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Oak Lawn, Illinois, 60453, United States
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Indianapolis, Indiana, 46202, United States
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West Des Moines, Iowa, 50266, United States
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Bardstown, Kentucky, 40004, United States
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Lexington, Kentucky, 40517, United States
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Shreveport, Louisiana, 71105, United States
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Jackson, Mississippi, 39216, United States
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Columbia, Missouri, 65212, United States
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Lincoln, Nebraska, 68504, United States
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Omaha, Nebraska, 68114, United States
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Gallup, New Mexico, 87301, United States
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Shiprock, New Mexico, 87420, United States
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Syracuse, New York, 13210, United States
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Boone, North Carolina, 28607, United States
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Cincinnati, Ohio, 45229, United States
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Cleveland, Ohio, 44109, United States
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Cleveland, Ohio, 44121, United States
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Columbus, Ohio, 43205, United States
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Dayton, Ohio, 45406, United States
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Dayton, Ohio, 45414, United States
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Oklahoma City, Oklahoma, 73104, United States
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Erie, Pennsylvania, 16506, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Warwick, Rhode Island, 02886, United States
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North Charleston, South Carolina, 29406, United States
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Sioux Falls, South Dakota, 57105, United States
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Kingsport, Tennessee, 37660, United States
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Memphis, Tennessee, 38103, United States
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Tullahoma, Tennessee, 37388, United States
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Baytown, Texas, 77521, United States
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Dallas, Texas, 75251, United States
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Edinburg, Texas, 78539, United States
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League City, Texas, 77573, United States
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Longview, Texas, 75605, United States
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Pearland, Texas, 77584, United States
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San Antonio, Texas, 78240, United States
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San Antonio, Texas, 78249, United States
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Tomball, Texas, 77375, United States
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Layton, Utah, 84041, United States
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Roy, Utah, 84067, United States
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Salt Lake City, Utah, 84107, United States
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Salt Lake City, Utah, 84123, United States
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South Jordan, Utah, 84095, United States
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St. George, Utah, 84790, United States
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Charlottesville, Virginia, 22902, United States
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Richmond, Virginia, 23219, United States
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Seattle, Washington, 98105, United States
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Morgantown, West Virginia, 26506, United States
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Marshfield, Wisconsin, 54449, United States
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San Miguel de Tucumán, 4000, Argentina
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San Miguel de Tucumán, T4000NWB, Argentina
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Clayton, 3168, Australia
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Nedlands, 6009, Australia
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Graz, 8036, Austria
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Vienna, 1090, Austria
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Bruges, 8000, Belgium
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Brussels, 1000, Belgium
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Brussels, 1070, Belgium
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Brussels, 1090, Belgium
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Ghent, 9000, Belgium
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Montana, 3400, Bulgaria
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Pazardzhik, 4400, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4000, Bulgaria
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Plovdiv, 4002, Bulgaria
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Rousse, 7002, Bulgaria
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Sofia, 1407, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Calgary, Alberta, T3B 6A8, Canada
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Vancouver, British Columbia, V6H 3V4, Canada
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Pierrefonds, Quebec, H9H 4Y6, Canada
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Santiago, 8880465, Chile
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Cali, Colombia
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Chía, 250002, Colombia
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Medellín, 50036, Colombia
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Medellín, 500515, Colombia
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Montería, 230002, Colombia
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Soledad, 083001, Colombia
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Havlíčkův Brod, 580 22, Czechia
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Paide, 72713, Estonia
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Tallinn, 10117, Estonia
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Tallinn, 10617, Estonia
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Tallinn, 13419, Estonia
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Tartu, 50406, Estonia
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Espoo, 02230, Finland
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Helsinki, 00100, Finland
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Jarvenpaa, 04400, Finland
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Kokkola, 67100, Finland
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Oulu, 90220, Finland
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Pori, 28100, Finland
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Seinäjoki, 60100, Finland
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Tampere, 33100, Finland
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Turku, 20520, Finland
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Amiens, 80054, France
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Bordeaux, 33000, France
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Brest, 29609, France
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Bron, 69677, France
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Caen, 14033, France
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Créteil, 94010, France
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Lille, 59020, France
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Frankenthal, 67227, Germany
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Leipzig, 04103, Germany
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Mannheim, 68161, Germany
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Beersheba, 84001, Israel
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Netanya, 4244916, Israel
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Roma, 00137, Italy
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Fukuyama-shi, 721-8511, Japan
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Kawasaki-shi, 210-0013, Japan
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Maebashi, 371-0811, Japan
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Okayama, 701-1192, Japan
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Osaka, 556-0005, Japan
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Sapporo, 062-0931, Japan
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Shizuoka, 420-0005, Japan
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Yokosuka-shi, 238-8558, Japan
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Jēkabpils, LV-5201, Latvia
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Riga, 1004, Latvia
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Riga, LV1002, Latvia
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Valmiera, 4200, Latvia
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Valmiera, LV-4201, Latvia
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Kaunas, 48259, Lithuania
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Kaunas, 50161, Lithuania
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México, 06720, Mexico
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Christchurch, 8011, New Zealand
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Grafton, 1023, New Zealand
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Papatoetoe, 2025, New Zealand
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Wellington, 6021, New Zealand
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Cuidad de Panama, Panama
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David, Panama
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La Chorrera, Panama
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Panama City, Panama
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Krakow, 30-348, Poland
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Krakow, 30-363, Poland
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Torun, 87-100, Poland
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Wroclaw, 51-169, Poland
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Wroclaw, 53-149, Poland
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Łęczna, 21-010, Poland
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Perm, 614066, Russia
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Saint Petersburg, 191025, Russia
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Saint Petersburg, 193312, Russia
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Saint Petersburg, 196084, Russia
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Cape Town, 7505, South Africa
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Cape Town, 7530, South Africa
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Cape Town, 7800, South Africa
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Durban, 4091, South Africa
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Johannesburg, 2112, South Africa
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Johannesburg, 2193, South Africa
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Pretoria, 0087, South Africa
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Pretoria, 0101, South Africa
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Rondebosch, 7700, South Africa
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Soweto, 2013, South Africa
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Incheon, 22332, South Korea
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Seoul, 03722, South Korea
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Alicante, 03010, Spain
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Antequera, 29200, Spain
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Castellon, 12004, Spain
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Córdoba, 14004, Spain
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Granada, 18014, Spain
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Leganés, 28911, Spain
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Lleida, 25198, Spain
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Madrid, 28040, Spain
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Málaga, 29004, Spain
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Móstoles, 28938, Spain
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Pozuelo de Alarcón, 28223, Spain
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San Cristóbal de La Laguna, 38320, Spain
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Sant Cugat del Vallès, 08190, Spain
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Sant Joan d'Alacant, 03550, Spain
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Santiago de Compostela, 15706, Spain
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Valencia, 46017, Spain
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Linköping, 587 58, Sweden
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Stockholm, 118 83, Sweden
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Adana, 01330, Turkey (Türkiye)
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Ankara, 06100, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Kocaeli, 41380, Turkey (Türkiye)
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Chernivtsі, 58001, Ukraine
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Dnipro, 49027, Ukraine
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Kyiv, 04050, Ukraine
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Sumy, 40022, Ukraine
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Vinnytsia, 21021, Ukraine
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Liverpool, L12 2AP, United Kingdom
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London, SW17 0RE, United Kingdom
Related Publications (8)
Bolanos R, Araos R, Gonzalez C, Sepulveda D, Falconi JF, Averin A, Atwood M, Quinn E, Law AW, Mendes D. Cost-effectiveness of strategies using preventive interventions to protect infants in Chile from respiratory syncytial virus. Expert Rev Vaccines. 2025 Dec;24(1):904-913. doi: 10.1080/14760584.2025.2562201. Epub 2025 Oct 2.
PMID: 40958705DERIVEDArbetter D, Gopalakrishnan V, Aksyuk AA, Ahani B, Chang Y, Dagan R, Esser MT, Hammitt LL, Mankad VS, Saez-Llorens X, Shen D, Leach A, Kelly EJ, Villafana T, Wilkins D. Lower Respiratory Tract Infections Following Respiratory Syncytial Virus Monoclonal Antibody Nirsevimab Immunization Versus Placebo: Analysis From a Phase 3 Randomized Clinical Trial (MELODY). Clin Infect Dis. 2025 Oct 6;81(3):634-644. doi: 10.1093/cid/ciae596.
PMID: 39656748DERIVEDLanger S, Holzapfel S, August L, Badura A, Wellmann S, Mack I. Parental knowledge and attitudes to infant immunization in the context of RSV: All about confidence? Vaccine. 2024 Oct 3;42(23):126050. doi: 10.1016/j.vaccine.2024.06.018. Epub 2024 Jun 19.
PMID: 38902186DERIVEDDagan R, Hammitt LL, Seoane Nunez B, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, Zar HJ, Chang Y, Currie A, Grenham A, Shroff M, Takas T, Mankad VS, Leach A, Villafana T. Infants Receiving a Single Dose of Nirsevimab to Prevent RSV Do Not Have Evidence of Enhanced Disease in Their Second RSV Season. J Pediatric Infect Dis Soc. 2024 Feb 26;13(2):144-147. doi: 10.1093/jpids/piad113.
PMID: 38219024DERIVEDAhani B, Tuffy KM, Aksyuk AA, Wilkins D, Abram ME, Dagan R, Domachowske JB, Guest JD, Ji H, Kushnir A, Leach A, Madhi SA, Mankad VS, Simoes EAF, Sparklin B, Speer SD, Stanley AM, Tabor DE, Hamren UW, Kelly EJ, Villafana T. Molecular and phenotypic characteristics of RSV infections in infants during two nirsevimab randomized clinical trials. Nat Commun. 2023 Jul 19;14(1):4347. doi: 10.1038/s41467-023-40057-8.
PMID: 37468530DERIVEDMuller WJ, Madhi SA, Seoane Nunez B, Baca Cots M, Bosheva M, Dagan R, Hammitt LL, Llapur CJ, Novoa JM, Saez Llorens X, Grenham A, Kelly EJ, Mankad VS, Shroff M, Takas T, Leach A, Villafana T; MELODY Study Group. Nirsevimab for Prevention of RSV in Term and Late-Preterm Infants. N Engl J Med. 2023 Apr 20;388(16):1533-1534. doi: 10.1056/NEJMc2214773. Epub 2023 Apr 5. No abstract available.
PMID: 37018470DERIVEDHammitt 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.
PMID: 35235726DERIVEDGinsburg 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.
PMID: 34774184DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- Astrazeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2019
First Posted
June 7, 2019
Study Start
July 23, 2019
Primary Completion
March 11, 2021
Study Completion
March 21, 2023
Last Updated
February 28, 2024
Results First Posted
February 28, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, 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.
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.