Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age

Summary

This study will assess the safety and immunogenicity of a fourth dose (booster) of BNT162b2 when coadministered with SIIV compared to separate administration of the vaccines when given 1 month apart (SIIV followed by BNT162b2), in participants who have received 3 prior doses of 30 µg BNT162b2, with the third dose being at least 90 days before Visit 1 (Day 1). * Healthy adults 18 through 64 years of age will be randomized 1:1 to either the co-administration group, or the separate administration group * The duration of the study for each participant will be approximately 2 months * There are 3 scheduled study visits each about 1 month apart * The study will be conducted in New Zealand and Australia.

Timeline

Start

2022-04-20

Primary completion

2022-10-05

Completion

2022-10-05

Publications

• Murdoch L, Quan K, Baber JA, Ho AWY, Zhang Y, Xu X, Lu C, Cooper D, Koury K, Lockhart SP, Anderson AS, Tureci O, Sahin U, Swanson KA, Gruber WC, Kitchin N; C4591030 Clinical Trial Group. Safety and Immunogenicity of the BNT162b2 Vaccine Coadministered with Seasonal Inactivated Influenza Vaccine in Adults. Infect Dis Ther. 2023 Sep;12(9):2241-2258. doi: 10.1007/s40121-023-00863-5. Epub 2023 Sep 12.

Drugs

Indications