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MATISSE trial (maternal RSV vaccine, infant outcomes)

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.

Also called MATISSE · C3671008

  • Study
  • In this atlas

Overview

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).
Phase
Phase 3
Enrolled
  • 14,727 participants, maternal and infant together (participant flow: 7420 maternal and 7307 infant participants) (enrolled count) (A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy., retrieved )
  • 3,682 maternal participants who received vaccine (paper abstract) (treated count) (Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants, retrieved )
  • 3,676 maternal participants who received placebo (paper abstract) (treated count) (Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants, retrieved )
  • 3,570 infants of vaccinated women who were evaluated (paper abstract) (unknown count) (Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants, retrieved )
  • 3,558 infants of placebo recipients who were evaluated (paper abstract) (unknown count) (Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants, retrieved )
Sponsor
Not recorded
Funder
Not recorded
Registry
  • NCT NCT04424316
Started
(actual) (A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy., retrieved )
Primary completion
(actual) (A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy., retrieved )
Completion
(actual) (A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy., retrieved )
Results first posted
(actual) (A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy., retrieved )
Countries
United States, Argentina, Australia, Brazil, Canada, Chile, Denmark, Finland, Japan, Mexico, Netherlands, New Zealand, Philippines, South Africa, South Korea, Spain, Taiwan, Gambia (A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy., retrieved )
Care setting
Pregnant women recruited at sites in 18 countries; the abstract gives no further detail of the care setting. (Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants, retrieved )
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

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.

Arms

  • RSVpreF vaccine

    Intervention RSVpreF (bivalent RSV prefusion F protein vaccine)

    A single intramuscular injection of 120 micrograms of bivalent RSV prefusion F protein vaccine (PubMed abstract); the registry arm is labelled RSVpreF vaccine.

  • Placebo

    Intervention None named

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

Findings

No findings are published for this study.

Record details

Record id
maternal:matisse-trial
Content hash
e6bb7b0a6f0e9d8e9c18d266b9de5c8637c1edb585708ec67bd424abfe24c13d