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MELODY trial (nirsevimab in healthy late-preterm and term infants)

A large international trial in which healthy babies born at 35 weeks or later received one injection of the RSV antibody nirsevimab or a placebo before an RSV season. The antibody lowered RSV lung infections that needed medical attention. For hospital admission for RSV, the secondary outcome, the result was less clear (P = 0.07).

Also called MELODY

  • Study
  • In this atlas

Overview

Design
Phase 3, randomised, double-blind, placebo-controlled trial in infants. Registry values: allocation randomized, intervention model parallel, masking quadruple, primary purpose prevention. Infants born at a gestational age of at least 35 weeks were randomised 2:1 to a single intramuscular injection of nirsevimab or placebo before the start of an RSV season (PubMed abstract).
Phase
Phase 3
Enrolled
  • 3,012 infants, all subjects (participant flow: 1003 placebo and 2009 nirsevimab; ClinicalTrials.gov gives no unit in the count field) (enrolled count) (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), retrieved )
  • 1,490 infants in the primary cohort (paper abstract; participant flow: 496 placebo and 994 nirsevimab) (randomized count) (Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants, retrieved )
Sponsor
Not recorded
Funder
Not recorded
Registry
  • NCT NCT03979313
Started
(actual) (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), retrieved )
Primary completion
(actual) (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), retrieved )
Completion
(actual) (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), retrieved )
Results first posted
(actual) (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), retrieved )
Countries
United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Czechia, Estonia, Finland, France, Germany, Israel, Italy, Japan, Latvia, Lithuania, Mexico, New Zealand, Panama, Poland, Russia, South Africa, South Korea, Spain, Sweden, Türkiye, Ukraine, United Kingdom (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), retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Registry NCT03979313 (MELODY), lead sponsor AstraZeneca (industry), phase 3, interventional, randomised, parallel, quadruple masking, prevention; COMPLETED. Registry enrolment is 3012 (actual); the registry's participant flow lists all subjects as 1003 placebo and 2009 nirsevimab infants, and the Primary Cohort as 496 placebo and 994 nirsevimab, which are the 1490 infants randomised in the paper's abstract; each count is recorded with its own basis. Results first posted on the registry on 2024-02-28. The paper (2022) was read as a PubMed abstract only. The registry lists 31 countries across Europe, the Americas, Asia, Africa and Oceania.

Arms

  • Nirsevimab (MEDI8897)

    Intervention Nirsevimab

    A single intramuscular injection of nirsevimab (PubMed abstract); the registry arm is labelled MEDI8897.

  • Placebo

    Intervention None named

    A single placebo injection (registry arm label: Placebo).

Findings

No findings are published for this study.

Record details

Record id
maternal:melody-trial
Content hash
b14d8cfc9698babcde1828a79ead35455a994e76fc04c2403ee2b936523b3d23