A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults

Summary

The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine formulations when administered alone or concomitantly with seasonal inactivated influenza vaccine (SIIV).

Timeline

Start

2018-04-18

Primary completion

2019-11-20

Completion

2020-12-28

Publications

• Walsh EE, Falsey AR, Zareba AM, Jiang Q, Gurtman A, Radley D, Gomme E, Cooper D, Jansen KU, Gruber WC, Swanson KA, Schmoele-Thoma B. Respiratory Syncytial Virus Prefusion F Vaccination: Antibody Persistence and Revaccination. J Infect Dis. 2024 Oct 16;230(4):e905-e916. doi: 10.1093/infdis/jiae185.
• Walsh EE, Falsey AR, Scott DA, Gurtman A, Zareba AM, Jansen KU, Gruber WC, Dormitzer PR, Swanson KA, Radley D, Gomme E, Cooper D, Schmoele-Thoma B. A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine. J Infect Dis. 2022 Apr 19;225(8):1357-1366. doi: 10.1093/infdis/jiab612.
• Falsey AR, Walsh EE, Scott DA, Gurtman A, Zareba A, Jansen KU, Gruber WC, Dormitzer PR, Swanson KA, Jiang Q, Gomme E, Cooper D, Schmoele-Thoma B. Phase 1/2 Randomized Study of the Immunogenicity, Safety, and Tolerability of a Respiratory Syncytial Virus Prefusion F Vaccine in Adults With Concomitant Inactivated Influenza Vaccine. J Infect Dis. 2022 Jun 15;225(12):2056-2066. doi: 10.1093/infdis/jiab611.

Drugs

Indications