{ "release_id": "c7fb95f1d15a7d13", "id": "maternal:melody-trial", "owner": "maternal", "kind": "study", "slug": "melody-trial", "name": "MELODY trial (nirsevimab in healthy late-preterm and term infants)", "aliases": [ "MELODY" ], "atlases": [ "maternal" ], "summary_plain": "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).", "summary_technical": "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.", "editorial_state": "draft", "last_substantive_edit": "2026-10-15", "last_evidence_check": "2026-10-15", "next_review_due": null, "identifiers": [ { "scheme": "nct", "value": "NCT03979313", "normalized_value": "NCT03979313", "match": "exact", "version": null, "label": null, "from_source": false } ], "navigation": { "maternal": { "life-stage": [ "newborn", "infant-follow-up" ], "care-area": [ "infant-health" ] } }, "payload": { "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).", "drug_phase": "3", "registry_statuses": [ { "status": "COMPLETED", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" } ], "start_date": { "date": "2019-07-23", "type": "actual", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, "primary_completion_date": { "date": "2021-03-11", "type": "actual", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, "completion_date": { "date": "2023-03-21", "type": "actual", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, "results_first_posted": { "date": "2024-02-28", "type": "actual", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, "countries": [ { "code": "US", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "AR", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "AU", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "AT", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "BE", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "BG", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "CA", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "CL", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "CO", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "CZ", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "EE", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "FI", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "FR", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "DE", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "IL", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "IT", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "JP", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "LV", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "LT", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "MX", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "NZ", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "PA", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "PL", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "RU", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "ZA", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "KR", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "ES", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "SE", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "TR", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "UA", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "code": "GB", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" } ], "care_setting": null, "stopped_early": null, "enrollment": [ { "count": 3012, "basis": "enrolled", "unit": "infants, all subjects (participant flow: 1003 placebo and 2009 nirsevimab; ClinicalTrials.gov gives no unit in the count field)", "snapshot": "maternal:ctgov-nct03979313-2026-10-15" }, { "count": 1490, "basis": "randomized", "unit": "infants in the primary cohort (paper abstract; participant flow: 496 placebo and 994 nirsevimab)", "snapshot": "maternal:pubmed-35235726-2026-10-15" } ], "arms": [ { "id": "maternal:melody-trial-arm-nirsevimab", "label": "Nirsevimab (MEDI8897)", "intervention": "maternal:nirsevimab", "description": "A single intramuscular injection of nirsevimab (PubMed abstract); the registry arm is labelled MEDI8897." }, { "id": "maternal:melody-trial-arm-placebo", "label": "Placebo", "intervention": null, "description": "A single placebo injection (registry arm label: Placebo)." } ], "findings": [] }, "content_digest": "b14d8cfc9698babcde1828a79ead35455a994e76fc04c2403ee2b936523b3d23", "review": { "content_digest": "b14d8cfc9698babcde1828a79ead35455a994e76fc04c2403ee2b936523b3d23", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [], "decisions": [], "milestones": [], "relationships": { "outgoing": [ { "predicate": "investigates", "label": "Tests a single dose of nirsevimab in infants", "clinical_claim_not_fact": false, "family": "sourced", "other_entity_id": "maternal:nirsevimab", "other_entity_in_atlas": true, "claim_id": null, "evidence": { "snapshot_id": "maternal:ctgov-nct03979313-2026-10-15", "locator": "protocolSection.armsInterventionsModule.interventions[0].name" }, "primary": false, "role": null, "valid_from": null, "valid_to": null } ], "incoming": [] }, "page_path": "studies/melody-trial/", "context_path": "api/v1/context/maternal--melody-trial.md" }