{
  "release_id": "c7fb95f1d15a7d13",
  "id": "maternal:matisse-trial",
  "owner": "maternal",
  "kind": "study",
  "slug": "matisse-trial",
  "name": "MATISSE trial (maternal RSV vaccine, infant outcomes)",
  "aliases": [
    "MATISSE",
    "C3671008"
  ],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "A large international trial of an RSV vaccine given to pregnant women, with illness in their babies as the main outcome. Women were randomly given the vaccine or a placebo (a dummy injection). The vaccine lowered severe RSV lung illness in babies; for RSV illness of any severity at 90 days the results did not meet the trial's statistical success criterion.",
  "summary_technical": "Registry NCT04424316, lead sponsor Pfizer (sponsor class industry), phase 3, interventional, randomised, parallel, quadruple masking, prevention; COMPLETED. The registry enrolment of 14727 counts mothers and infants together (its participant flow says 7420 maternal participants and 7307 infant participants); the paper's counts (3682 and 3676 maternal participants who received vaccine or placebo, and 3570 and 3558 infants evaluated) are recorded with their own units. The trial paper (2023) was read as a PubMed abstract only. The abstract reports an interim analysis in which one of two primary end points met the success criterion.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": "2026-10-15",
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT04424316",
      "normalized_value": "NCT04424316",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "maternal": {
      "life-stage": [
        "pregnancy",
        "infant-follow-up"
      ],
      "care-area": [
        "infant-health"
      ]
    }
  },
  "payload": {
    "design": "Phase 3, randomised, double-blind, placebo-controlled trial in pregnant women, with the outcomes counted in their infants. Registry values: allocation randomized, intervention model parallel, masking quadruple, primary purpose prevention. Women at 24 through 36 weeks' gestation were randomised 1:1 to one injection of RSVpreF or placebo (PubMed abstract).",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      }
    ],
    "start_date": {
      "date": "2020-06-17",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
    },
    "primary_completion_date": {
      "date": "2023-10-27",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
    },
    "completion_date": {
      "date": "2023-10-27",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
    },
    "results_first_posted": {
      "date": "2025-02-11",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
    },
    "countries": [
      {
        "code": "US",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      },
      {
        "code": "AR",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      },
      {
        "code": "AU",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      },
      {
        "code": "BR",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      },
      {
        "code": "CA",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      },
      {
        "code": "CL",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      },
      {
        "code": "DK",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      },
      {
        "code": "FI",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      },
      {
        "code": "JP",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      },
      {
        "code": "MX",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      },
      {
        "code": "NL",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      },
      {
        "code": "NZ",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      },
      {
        "code": "PH",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      },
      {
        "code": "ZA",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      },
      {
        "code": "KR",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      },
      {
        "code": "ES",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      },
      {
        "code": "TW",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      },
      {
        "code": "GM",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      }
    ],
    "care_setting": {
      "description": "Pregnant women recruited at sites in 18 countries; the abstract gives no further detail of the care setting.",
      "snapshot": "maternal:pubmed-37018474-2026-10-15"
    },
    "stopped_early": null,
    "enrollment": [
      {
        "count": 14727,
        "basis": "enrolled",
        "unit": "participants, maternal and infant together (participant flow: 7420 maternal and 7307 infant participants)",
        "snapshot": "maternal:ctgov-nct04424316-2026-10-15"
      },
      {
        "count": 3682,
        "basis": "treated",
        "unit": "maternal participants who received vaccine (paper abstract)",
        "snapshot": "maternal:pubmed-37018474-2026-10-15"
      },
      {
        "count": 3676,
        "basis": "treated",
        "unit": "maternal participants who received placebo (paper abstract)",
        "snapshot": "maternal:pubmed-37018474-2026-10-15"
      },
      {
        "count": 3570,
        "basis": "unknown",
        "unit": "infants of vaccinated women who were evaluated (paper abstract)",
        "snapshot": "maternal:pubmed-37018474-2026-10-15"
      },
      {
        "count": 3558,
        "basis": "unknown",
        "unit": "infants of placebo recipients who were evaluated (paper abstract)",
        "snapshot": "maternal:pubmed-37018474-2026-10-15"
      }
    ],
    "arms": [
      {
        "id": "maternal:matisse-trial-arm-vaccine",
        "label": "RSVpreF vaccine",
        "intervention": "maternal:rsvpref-vaccine",
        "description": "A single intramuscular injection of 120 micrograms of bivalent RSV prefusion F protein vaccine (PubMed abstract); the registry arm is labelled RSVpreF vaccine."
      },
      {
        "id": "maternal:matisse-trial-arm-placebo",
        "label": "Placebo",
        "intervention": null,
        "description": "A single placebo injection (registry arm label: Placebo dose)."
      }
    ],
    "findings": []
  },
  "content_digest": "e6bb7b0a6f0e9d8e9c18d266b9de5c8637c1edb585708ec67bd424abfe24c13d",
  "review": {
    "content_digest": "e6bb7b0a6f0e9d8e9c18d266b9de5c8637c1edb585708ec67bd424abfe24c13d",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests RSV vaccination in pregnancy for infant outcomes",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:maternal-rsv-vaccination",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:ctgov-nct04424316-2026-10-15",
          "locator": "protocolSection.identificationModule.briefTitle"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "The vaccine substance tested",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:rsvpref-vaccine",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:ctgov-nct04424316-2026-10-15",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/matisse-trial/",
  "context_path": "api/v1/context/maternal--matisse-trial.md"
}