Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 OA Investigational Vaccine in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study

Summary

Nine different formulations of the RSVPreF3 OA investigational vaccine were tested in the parent study (NCT03814590). Based on safety and immunogenicity data from the parent study, RSVPreF3 OA investigational vaccine will be evaluated in further clinical research. Participants in selected groups will be invited to participate in this extension study. All participants who will be enrolled in the current extension study will receive the RSV investigational vaccine approximately 18 months after they received their respective dose-2 in the parent study.

Timeline

Start

2020-12-09

Primary completion

2021-06-03

Completion

2021-10-25

Publications

• Leroux-Roels I, Van Ranst M, Vandermeulen C, Abeele CV, De Schrevel N, Salaun B, Verheust C, David MP, Kotb S, Hulstrom V. Safety and Immunogenicity of a Revaccination With a Respiratory Syncytial Virus Prefusion F Vaccine in Older Adults: A Phase 2b Study. J Infect Dis. 2024 Feb 14;229(2):355-366. doi: 10.1093/infdis/jiad321.

Drugs

Indications