A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults

Summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 doses of GSK Biologicals' RSV candidate vaccine adjuvanted with AS01B for the prevention of lower respiratory tract diseases caused by RSV in ethnic Japanese adults 60-80 years of age.

Timeline

Start

2019-09-25

Primary completion

2020-01-10

Completion

2020-12-11

Publications

• Kotb S, Haranaka M, Folschweiller N, Nakanwagi P, Verheust C, De Schrevel N, David MP, Mesaros N, Hulstrom V. Safety and immunogenicity of a respiratory syncytial virus prefusion F protein (RSVPreF3) candidate vaccine in older Japanese adults: A phase I, randomized, observer-blind clinical trial. Respir Investig. 2023 Mar;61(2):261-269. doi: 10.1016/j.resinv.2022.11.003. Epub 2023 Jan 12.

Drugs

Indications