A Phase 2b, Non-randomized, Controlled, Open-label, Extension Study to Evaluate the Persistence of Immune Response of the Adjuvanted RSVPreF3 Vaccine and the Safety and Immunogenicity Following Revaccination in Lung and Kidney Transplant Recipients (>=18 Years of Age)
GlaxoSmithKline
Summary
This study evaluates persistence of the immune response of the adjuvanted RSV vaccine and the safety and immunogenicity following revaccination in adults 18 years of age and above who received lung or kidney transplant.
Description
Lung or kidney transplant recipients undergoing chronic immunosuppressive therapy, who received 1 (IC\_1 group) and 2 (IC\_2 group) doses of the adjuvanted RSVPreF3 vaccine in the RSV OA=ADJ-023 study \[parent study; NCT05921903\], will receive an additional dose of the adjuvanted RSVPreF3 vaccine in the current study. As pre-assigned in protocol, the participants that received 1 dose and 2 doses of adjuvanted RSVPreF3 vaccine in the parent study will be analysed separately in the current study for the immune response analyses, and under an overall group (IC Revaccination group) for the demogr…