Lot-to-lot consistency, immunogenicity, and safety of a 23-valent pneumococcal polysaccharide vaccine (PPV23) in healthy adults aged 40-65 years: A randomized, double-blind, controlled, phase IV clinical trial.

ABSTRACT: This randomized, double-blind, phase IV study (NCT05731115) assessed the lot-to-lot consistency, immunogenicity, and safety of three manufacturing lots of a 23-valent pneumococcal polysaccharide vaccine (PPV23) in 1800 healthy Chinese adults aged 40-65 y. The participants were enrolled and randomized into three groups at a 1:1:1 ratio, with each group receiving one dose of PPV23 from one of three manufacturing lots. Blood samples were collected pre-vaccination and at 30 d post-vaccination for serotype-specific IgG antibody testing. The primary objective was to demonstrate lot-to-lot consistency via equivalence evaluation in 40-65 y old Chinese adults, assessed by geometric mean concentration (GMC) of IgG antibodies at 30 d post-vaccination. Safety data were collected for up to 30 d after v

SUBMITTER: Zhang Y 

PROVIDER: S-EPMC12584606 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature