Safety and Immunogenicity of V114, a 15-valent Pneumococcal Conjugate Vaccine, Compared With 13- valent Pneumococcal Vaccine in Japanese Adults Aged ≥65 Years: Subgroup Analysis of a Randomized Phase III Trial (PNEU-AGE)

Abstract

The safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine (PCV), was assessed in a pivotal Phase III trial in healthy adults ≥50 years of age (NCT03950622, Japic-CTI 194845). We report a subgroup analysis of 245 Japanese participants (all ≥65 years of age). Participants were randomized 1:1 to receive a single dose of V114 or 13-valent PCV (PCV13). Immune responses were evaluated at baseline and 30 days post-vaccination. Non-serious and serious adverse events (AEs) were evaluated post-vaccination through 14 days and 6 months, respectively. Proportions of participants experiencing solicited and serious AEs were comparable for both vaccines; all solicited AEs were mild or moderate in severity. Serotype-specific opsonophagocytic activity (OPA) geometric mean titers at 30 days post-vaccination were comparable between groups for all 13 shared serotypes and higher with V114 for the unique serotypes 22F and 33F. Proportions of participants with a ≥4-fold rise in serotype-specific OPA responses from pre-vaccination to 30 days post-vaccination were higher with V114 than PCV13 for serotypes 3, 22F, and 33F. V114 was well tolerated and immunogenic in Japanese adults ≥65 years of age, with safety and immunogenicity profiles consistent with that seen in the overall study population.