Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

Summary

The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 5 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules.

Timeline

Start

2021-02-15

Primary completion

2022-06-06

Completion

2027-02-19

Publications

• Background Schwarz TF, Hwang SJ, Ylisastigui P, Liu CS, Takazawa K, Yono M, Ervin JE, Andrews CP, Fogarty C, Eckermann T, Collete D, de Heusch M, De Schrevel N, Salaun B, Lambert A, Marechal C, Olivier A, Nakanwagi P, Lievens M, Hulstrom V. Immunogenicity and Safety Following 1 Dose of AS01E-Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults: A Phase 3 Trial. J Infect Dis. 2024 Jul 25;230(1):e102-e110. doi: 10.1093/infdis/jiad546.

Drugs

Indications