This site is intended for healthcare professionals
Latest drug news
  • Home
  • /
  • News
  • /
  • 2022
  • /
  • 11
  • /
  • Phase III MATISSE trial of RSVpreF vaccine meets o...

Phase III MATISSE trial of RSVpreF vaccine meets one primary endpoint in Respiratory Syncytial Virus

Read time: 1 mins
Published:2nd Nov 2022

Pfizer announced positive top-line data from the Phase III clinical trial (NCT04424316) MATISSE (MATernal Immunization Study for Safety and Efficacy) investigating its bivalent Respiratory Syncytial Virus (RSV) prefusion vaccine candidate, RSVpreF or PF 06928316, when administered to pregnant participants to help protect their infants from RSV disease after birth

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. The observed efficacy for severe medically attended lower respiratory tract illness (severe MA-LRTI) was 81.8% (CI: 40.6%, 96.3%) through the first 90 days of life. Substantial efficacy of 69.4% (CI: 44.3%, 84.1%) was demonstrated for infants over the six-month follow-up period.

Although the statistical success criterion was not met for the second primary endpoint, clinically meaningful efficacy was observed for MA-LRTI of 57.1% (CI: 14.7%, 79.8%) in infants from birth through the first 90 days of life. Efficacy for MA-LRTI of 51.3% (CI: 29.4%, 66.8%) was observed over the six-month follow up period.

Pre-planned safety reviews conducted at regular intervals throughout the duration of the study by the DMC also indicate the investigational vaccine is well-tolerated with no safety concerns for both the vaccinated individuals and their newborns. At the recommendation of the DMC, and in consultation with the U.S. Food and Drug Administration (FDA), Pfizer has stopped enrollment in the study. Based on these positive results Pfizer plans to submit a Biologics License Application (BLA) to the FDA by the end of 2022 for the vaccine candidate followed by other regulatory authorities in the coming months.

Condition: Respiratory Syncytial Virus
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.