A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above

Summary

The aim of this study is to demonstrate the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for RSV disease, compared to older adults (OA) 60 YOA and above.

Timeline

Start

2024-04-29

Primary completion

2024-07-29

Completion

2025-03-18

Outcome

Met primary endpoint

paper Immunological noninferiority was demonstrated in the at-risk 18-49 versus ≥60 group at 1 month postvaccination. PMID 41757519 ↗

Publications

• Mitha E, Ferguson M, Wilhase AC, De Looze F, Vachon ML, Stacey H, Rasalam R, Nozaki M, Smith WB, Schwarz TF, Hailemariam HA, Deraedt Q, Gerard C, Vanden Abeele C, Damaso S, Descamps D, Hill J, Dasyam D, Van Gucht J, Hulstrom V. Immunogenicity and Safety of the AS01E-adjuvanted Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine in Adults Aged 18-49 Years at Increased Risk of RSV Disease Compared with Adults Aged >/=60 Years. Clin Infect Dis. 2026 May 20;82(5):e1093-e1103. doi: 10.1093/cid/ciag058.

Drugs

Indications