A Study on the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers

Summary

The purpose of this study was to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of the respiratory syncytial virus (RSV) maternal vaccine compared to placebo, when administered in the second or third trimester of pregnancy in women, 15 to 49 years of age (YOA), with high risk pregnancies and in the infants born to the vaccinated mothers. Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants at that time continued to be monitored as part of the study.

Timeline

Start

2021-08-03

Primary completion

2023-05-30

Completion

2023-05-30

Outcome

Outcome not reported

Stopped: “Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study.”

Publications

• Bebia Z, Dieussaert I, Jose L, Kantele A, Valimaa H, Middleton G, Pirela HDE, Reyes O, Sanchez MG, Vigil-De Gracia P, Hua N, Kirabo M, Lese P, Kim JH. Randomized, placebo-controlled phase 3 trial evaluating safety, immunogenicity, and reactogenicity of RSVPreF3-Mat in high-risk pregnant women and their infants. Hum Vaccin Immunother. 2026 Dec;22(1):2613565. doi: 10.1080/21645515.2026.2613565. Epub 2026 Mar 1.

Drugs

Indications