A prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the recombinant zoster vaccine in Chinese adults ≥50 years of age.

ABSTRACT: This post-marketing surveillance study evaluated the safety of the adjuvanted recombinant zoster vaccine (RZV) in Chinese adults, given the limited country-specific safety data accumulated since the 2019 licensure of RZV in China for adults ≥ 50 years of age (YOA). This descriptive, prospective cohort study enrolled adults ≥ 50 YOA who voluntarily received RZV per routine clinical practice in six centers in China. The primary outcomes were occurrence, intensity, and causal relationship to vaccination of medically attended adverse events (MAEs) within 30 days post-any dose. The occurrence and causal relationship to RZV of serious AEs (SAEs) within 30 days post-any dose, and of SAEs and potential immune-mediated diseases (pIMDs) from dose 1 until 12 months post-last dose were secondary outco

SUBMITTER: Pang X 

PROVIDER: S-EPMC11651282 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature