A Phase III, Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers

Summary

The purpose of this study was to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly (IM) to pregnant women aged 18-49 years, in good general maternal health, in preventing medically assessed RSV associated Lower Respiratory Tract Illnesses (LRTIs) in infants born to vaccinated mothers. The study also evaluated the safety of the investigational RSV Maternal vaccine both in vaccinated mothers and in their corresponding infant. 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

2020-11-20

Primary completion

2023-06-14

Completion

2023-06-14

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

• Background Dieussaert I, Hyung Kim J, Luik S, Seidl C, Pu W, Stegmann JU, Swamy GK, Webster P, Dormitzer PR. RSV Prefusion F Protein-Based Maternal Vaccine - Preterm Birth and Other Outcomes. N Engl J Med. 2024 Mar 14;390(11):1009-1021. doi: 10.1056/NEJMoa2305478.
• Banooni P, Gonik B, Epalza C, Reyes O, Madhi SA, Gomez-Go GD, Zaman K, Llapur CJ, Lopez-Medina E, Stanley T, Kantele A, Huang LM, Mussi-Pinhata MM, Dewulf J, Langley JM, Seidl C, Ota M, Kirabo M, Anspach B, Dieussaert I, Henry O, Kim JH, Picciolato M. Efficacy, Immunogenicity, and Safety of an Investigational Maternal Respiratory Syncytial Virus Prefusion F Protein-Based Vaccine. Clin Infect Dis. 2026 Feb 9;82(1):e146-e155. doi: 10.1093/cid/ciaf033.
• 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

Indications