A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

Summary

This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants.

Timeline

Start

2020-06-17

Primary completion

2023-10-27

Completion

2023-10-27

Outcome

Mixed primary results

paper At this prespecified interim analysis, the success criterion for vaccine efficacy was met with respect to one primary end point. PMID 37018474 ↗

paper these results did not meet the statistical success criterion. PMID 37018474 ↗

release “Pfizer Inc. (NYSE: PFE) today announced positive top-line data from the Phase 3 clinical trial (NCT04424316) MATISSE” pfizer.com ↗

release “The pre-planned, interim efficacy analysis conducted by an external and independent Data Monitoring Committee (DMC) met the success criterion for one of two primary endpoints.” pfizer.com ↗

Publications

• Shittu E, Pahud BA, Radley D, Gurtman A, Munjal I. Efficacy and safety outcomes from the MATISSE phase 3 trial of maternal bivalent RSVpreF vaccination among pregnant women vaccinated at 32 to 36 weeks of gestation. Swiss Med Wkly. 2026 Jan 31;156:4711. doi: 10.57187/4711.
• 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.
• Ilangovan K, Radley D, Patton M, Shittu E, Lino MM, Goulas C, Swanson KA, Anderson AS, Gurtman A, Munjal I. Integrated Analysis of the Safety Experience in Adults with the Bivalent Respiratory Syncytial Virus Prefusion F Vaccine. Vaccines (Basel). 2025 Aug 1;13(8):827. doi: 10.3390/vaccines13080827.
• Simoes EAF, Pahud BA, Madhi SA, Kampmann B, Shittu E, Radley D, Llapur C, Baker J, Perez Marc G, Barnabas SL, Fausett M, Adam T, Perreras N, Van Houten MA, Kantele A, Huang LM, Bont LJ, Otsuki T, Vargas SL, Gullam J, Tapiero B, Stein RT, Polack FP, Zar HJ, Staerke NB, Padilla MD, Richmond PC, Sarwar UN, Baber J, Koury K, Lino MM, Kalinina EV, Li W, Cooper D, Anderson AS, Swanson KA, Gurtman A, Munjal I; MATISSE (Maternal Immunization Study for Safety and Efficacy) Clinical Trial Group. Efficacy, Safety, and Immunogenicity of the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Respiratory Syncytial Virus Prefusion F Protein Vaccine Trial. Obstet Gynecol. 2025 Feb 1;145(2):157-167. doi: 10.1097/AOG.0000000000005816. Epub 2025 Jan 2.
• Madhi SA, Kampmann B, Simoes EAF, Zachariah P, Pahud BA, Radley D, Sarwar UN, Shittu E, Llapur C, Perez Marc G, Maldonado Y, Kachikis A, Zar HJ, Swanson KA, Lino MM, Anderson AS, Gurtman A, Munjal I. Preterm Birth Frequency and Associated Outcomes From the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Trial of the Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine. Obstet Gynecol. 2025 Feb 1;145(2):147-156. doi: 10.1097/AOG.0000000000005817. Epub 2025 Jan 2.
• Nazareno AL, Wood JG, Muscatello DJ, Homaira N, Hogan AB, Newall AT. Estimating the cost-effectiveness of maternal respiratory syncytial virus (RSV) vaccination in Australia: A dynamic and economic modelling analysis. Vaccine. 2025 Feb 6;46:126651. doi: 10.1016/j.vaccine.2024.126651. Epub 2024 Dec 28.
• Otsuki T, Akada S, Anami A, Kosaka K, Munjal I, Baber J, Shoji Y, Aizawa M, Swanson KA, Gurtman A. Efficacy and safety of bivalent RSVpreF maternal vaccination to prevent RSV illness in Japanese infants: Subset analysis from the pivotal randomized phase 3 MATISSE trial. Vaccine. 2024 Sep 17;42(22):126041. doi: 10.1016/j.vaccine.2024.06.009. Epub 2024 Jun 8.
• Kampmann B, Madhi SA, Munjal I, Simoes EAF, Pahud BA, Llapur C, Baker J, Perez Marc G, Radley D, Shittu E, Glanternik J, Snaggs H, Baber J, Zachariah P, Barnabas SL, Fausett M, Adam T, Perreras N, Van Houten MA, Kantele A, Huang LM, Bont LJ, Otsuki T, Vargas SL, Gullam J, Tapiero B, Stein RT, Polack FP, Zar HJ, Staerke NB, Duron Padilla M, Richmond PC, Koury K, Schneider K, Kalinina EV, Cooper D, Jansen KU, Anderson AS, Swanson KA, Gruber WC, Gurtman A; MATISSE Study Group. Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants. N Engl J Med. 2023 Apr 20;388(16):1451-1464. doi: 10.1056/NEJMoa2216480. Epub 2023 Apr 5.
• 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	RSVpreF	Vaccine	120 ug	Intramuscular

Indications