Safety and Immunogenicity of RSVpreF Coadministered With SIIV in Adults ≥65 Years of Age

Summary

The purpose of this study is to assess the safety and immunogenicity of RSVpreF when coadministered with SIIV compared to sequential administration of the vaccines when given 1 month apart (SIIV followed by RSVpreF). Additionally, the study will contribute data supporting the development of RSVpreF as a prophylactic vaccine against RSV disease in infants through maternal immunization and in older adults through active vaccination.

Timeline

Start

2022-04-13

Primary completion

2022-10-12

Completion

2022-10-12

Outcome

Met primary endpoint

paper All comparisons achieved the prespecified 1.5-fold noninferiority margin. PMID 37992000 ↗

paper The primary study objectives were met, demonstrating noninferiority of RSVpreF and SIIV immune responses PMID 37992000 ↗

Publications

• Athan E, Baber J, Quan K, Scott RJ, Jaques A, Jiang Q, Li W, Cooper D, Cutler MW, Kalinina EV, Anderson AS, Swanson KA, Gruber WC, Gurtman A, Schmoele-Thoma B; Study C3671006 Investigator Group. Safety and Immunogenicity of Bivalent RSVpreF Vaccine Coadministered With Seasonal Inactivated Influenza Vaccine in Older Adults. Clin Infect Dis. 2024 May 15;78(5):1360-1368. doi: 10.1093/cid/ciad707.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RSVpreF	Vaccine	—	—
Subject	Seasonal Inactivated Influenza Vaccine	Vaccine	—	—

Indications