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)
NCT ID: NCT03979313
Last Updated: 2024-02-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
3012 participants
INTERVENTIONAL
2019-07-23
2023-03-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children
NCT03959488
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
NCT02878330
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
NCT02290340
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety of MEDI-559 in Healthy 1 to <24 Month-Old Children
NCT00767416
Study to Evaluate the Safety of MEDI-534 Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) in Healthy Children
NCT00345670
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MEDI8897
Anti-RSV monoclonal antibody with an extended half-life
MEDI8897
Anti-RSV monoclonal antibody with an extended half-life
Placebo
Commercially available 0.9% (w/v) saline
Placebo
Commercially available 0.9% (w/v) saline
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MEDI8897
Anti-RSV monoclonal antibody with an extended half-life
Placebo
Commercially available 0.9% (w/v) saline
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Infants who are entering their first RSV season at the time of screening
Exclusion Criteria
* 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
0 Years
1 Year
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Birmingham, Alabama, United States
Research Site
Fort Defiance, Arizona, United States
Research Site
Fayetteville, Arkansas, United States
Research Site
Anaheim, California, United States
Research Site
Downey, California, United States
Research Site
National City, California, United States
Research Site
Paramount, California, United States
Research Site
West Covina, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Gainesville, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Fort Gordon, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Oak Lawn, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
West Des Moines, Iowa, United States
Research Site
Bardstown, Kentucky, United States
Research Site
Lexington, Kentucky, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Jackson, Mississippi, United States
Research Site
Columbia, Missouri, United States
Research Site
Lincoln, Nebraska, United States
Research Site
Omaha, Nebraska, United States
Research Site
Gallup, New Mexico, United States
Research Site
Shiprock, New Mexico, United States
Research Site
Syracuse, New York, United States
Research Site
Boone, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Dayton, Ohio, United States
Research Site
Dayton, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Erie, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Warwick, Rhode Island, United States
Research Site
North Charleston, South Carolina, United States
Research Site
Sioux Falls, South Dakota, United States
Research Site
Kingsport, Tennessee, United States
Research Site
Memphis, Tennessee, United States
Research Site
Tullahoma, Tennessee, United States
Research Site
Baytown, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Edinburg, Texas, United States
Research Site
League City, Texas, United States
Research Site
Longview, Texas, United States
Research Site
Pearland, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Tomball, Texas, United States
Research Site
Layton, Utah, United States
Research Site
Roy, Utah, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Salt Lake City, Utah, United States
Research Site
South Jordan, Utah, United States
Research Site
St. George, Utah, United States
Research Site
Charlottesville, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Seattle, Washington, United States
Research Site
Morgantown, West Virginia, United States
Research Site
Marshfield, Wisconsin, United States
Research Site
San Miguel de Tucumán, , Argentina
Research Site
San Miguel de Tucumán, , Argentina
Research Site
Clayton, , Australia
Research Site
Nedlands, , Australia
Research Site
Graz, , Austria
Research Site
Vienna, , Austria
Research Site
Bruges, , Belgium
Research Site
Brussels, , Belgium
Research Site
Brussels, , Belgium
Research Site
Brussels, , Belgium
Research Site
Ghent, , Belgium
Research Site
Montana, , Bulgaria
Research Site
Pazardzhik, , Bulgaria
Research Site
Pleven, , Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Rousse, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Veliko Tarnovo, , Bulgaria
Research Site
Calgary, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Pierrefonds, Quebec, Canada
Research Site
Santiago, , Chile
Research Site
Cali, , Colombia
Research Site
Chía, , Colombia
Research Site
Medellín, , Colombia
Research Site
Medellín, , Colombia
Research Site
Montería, , Colombia
Research Site
Soledad, , Colombia
Research Site
Havlíčkův Brod, , Czechia
Research Site
Paide, , Estonia
Research Site
Tallinn, , Estonia
Research Site
Tallinn, , Estonia
Research Site
Tallinn, , Estonia
Research Site
Tartu, , Estonia
Research Site
Espoo, , Finland
Research Site
Helsinki, , Finland
Research Site
Järvenpää, , Finland
Research Site
Kokkola, , Finland
Research Site
Oulu, , Finland
Research Site
Pori, , Finland
Research Site
Seinäjoki, , Finland
Research Site
Tampere, , Finland
Research Site
Turku, , Finland
Research Site
Amiens, , France
Research Site
Bordeaux, , France
Research Site
Brest, , France
Research Site
Bron, , France
Research Site
Caen, , France
Research Site
Créteil, , France
Research Site
Lille, , France
Research Site
Frankenthal, , Germany
Research Site
Leipzig, , Germany
Research Site
Mannheim, , Germany
Research Site
Beersheba, , Israel
Research Site
Netanya, , Israel
Research Site
Roma, , Italy
Research Site
Fukuyama-shi, , Japan
Research Site
Kawasaki-shi, , Japan
Research Site
Maebashi, , Japan
Research Site
Okayama, , Japan
Research Site
Osaka, , Japan
Research Site
Sapporo, , Japan
Research Site
Shizuoka, , Japan
Research Site
Yokosuka-shi, , Japan
Research Site
Jēkabpils, , Latvia
Research Site
Riga, , Latvia
Research Site
Riga, , Latvia
Research Site
Valmiera, , Latvia
Research Site
Valmiera, , Latvia
Research Site
Kaunas, , Lithuania
Research Site
Kaunas, , Lithuania
Research Site
México, , Mexico
Research Site
Christchurch, , New Zealand
Research Site
Grafton, , New Zealand
Research Site
Papatoetoe, , New Zealand
Research Site
Wellington, , New Zealand
Research Site
Cuidad de Panama, , Panama
Research Site
David, , Panama
Research Site
La Chorrera, , Panama
Research Site
Panama City, , Panama
Research Site
Krakow, , Poland
Research Site
Krakow, , Poland
Research Site
Torun, , Poland
Research Site
Wroclaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Łęczna, , Poland
Research Site
Perm, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Cape Town, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Durban, , South Africa
Research Site
Johannesburg, , South Africa
Research Site
Johannesburg, , South Africa
Research Site
Pretoria, , South Africa
Research Site
Pretoria, , South Africa
Research Site
Rondebosch, , South Africa
Research Site
Soweto, , South Africa
Research Site
Incheon, , South Korea
Research Site
Seoul, , South Korea
Research Site
Alicante, , Spain
Research Site
Antequera, , Spain
Research Site
Castellon, , Spain
Research Site
Córdoba, , Spain
Research Site
Granada, , Spain
Research Site
Leganés, , Spain
Research Site
Lleida, , Spain
Research Site
Madrid, , Spain
Research Site
Málaga, , Spain
Research Site
Móstoles, , Spain
Research Site
Pozuelo de Alarcón, , Spain
Research Site
San Cristóbal de La Laguna, , Spain
Research Site
Sant Cugat del Vallès, , Spain
Research Site
Sant Joan d'Alacant, , Spain
Research Site
Santiago de Compostela, , Spain
Research Site
Valencia, , Spain
Research Site
Linköping, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Adana, , Turkey (Türkiye)
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Izmir, , Turkey (Türkiye)
Research Site
Kocaeli, , Turkey (Türkiye)
Research Site
Chernivtsі, , Ukraine
Research Site
Dnipro, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Sumy, , Ukraine
Research Site
Vinnytsia, , Ukraine
Research Site
Liverpool, , United Kingdom
Research Site
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Arbetter 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. 2024 Dec 4:ciae596. doi: 10.1093/cid/ciae596. Online ahead of print.
Langer 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.
Dagan 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.
Ahani 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.
Muller 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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-000114-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D5290C00004
Identifier Type: -
Identifier Source: org_study_id
NCT05238974
Identifier Type: -
Identifier Source: nct_alias
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.