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)
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.
Timeline
- Start
- 2019-07-23
- Primary completion
- 2021-03-11
- Completion
- 2023-03-21
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Medi8897; p <0.0001; Relative Risk Reduction (RRR) 74.53 (95% CI 49.63 to 87.12) NCT03979313 ↗
paper Medically attended RSV-associated lower respiratory tract infection occurred in 12 infants (1.2%) in the nirsevimab group and in 25 infants (5.0%) in the placebo group; PMID 35235726 ↗
release “The MELODY Phase III trial for nirsevimab met its primary endpoint” astrazeneca.com ↗
release “Detailed results from the positive MELODY Phase III trial showed a single dose of AstraZeneca and Sanofi’s nirsevimab met the primary efficacy endpoint” astrazeneca.com ↗
release “The primary endpoint of the MELODY Phase III trial was met, reducing the incidence of medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV by 74.5%” astrazeneca.com ↗
release “The primary endpoint of the MELODY Phase III trial was met, reducing the incidence of medically attended LRTI” astrazeneca.com ↗
release “The primary endpoint of the MELODY Phase III trial was met” astrazeneca.com ↗
Publications
- 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. 2025 Oct 6;81(3):634-644. doi: 10.1093/cid/ciae596.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nirsevimab | Monoclonal antibody | — | Intramuscular |