A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above

Summary

The aim of this study is to demonstrate the non-inferiority (NI) of the immune response and evaluate safety of RSVPreF3 older adults (OA) investigational vaccine in adults 50-59 years of age (YOA), including those who are at increased risk (AIR) of respiratory syncytial virus (RSV)-lower respiratory tract disease (LRTD), versus adults \>=60 YOA

Timeline

Start

2022-10-28

Primary completion

2023-03-13

Completion

2024-02-12

Publications

• Ferguson M, Schwarz TF, Nunez SA, Rodriguez-Garcia J, Mital M, Zala C, Pek B, Schmitt B, Toursarkissian N, Ochoa Mazarro D, Grosskopf J, Voors-Pette C, Mehta H, Amare Hailemariam H, Gerard C, Damaso S, David MP, Descamps D, Hill J, Vandermeulen C, Hulstrom V. Immune persistence and safety of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in adults 50-59 years of age, including at-increased-risk adults: A randomized controlled trial. Hum Vaccin Immunother. 2025 Dec;21(1):2579335. doi: 10.1080/21645515.2025.2579335. Epub 2025 Nov 5.
• Ferguson M, Schwarz TF, Nunez SA, Rodriguez-Garcia J, Mital M, Zala C, Schmitt B, Toursarkissian N, Mazarro DO, Grosskopf J, Voors-Pette C, Mehta H, Hailemariam HA, de Heusch M, Salaun B, Damaso S, David MP, Descamps D, Hill J, Vandermeulen C, Hulstrom V; RSV OA=ADJ-018 Study Group. Noninferior Immunogenicity and Consistent Safety of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults 50-59 Years Compared to >/=60 Years of Age. Clin Infect Dis. 2024 Oct 15;79(4):1074-1084. doi: 10.1093/cid/ciae364.

Drugs

Indications