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