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

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).

Effectiveness, immunogenicity, and safety of the quadrivalent HPV vaccine in women and men aged 27-45 years.

Among women aged 27-45 years, the quadrivalent human papillomavirus (qHPV; HPV6/11/16/18) vaccine was generally well tolerated, efficacious, and immunogenic in the placebo-controlled FUTURE III study (NCT00090220; n = 3253). The qHPV vaccine was also generally well tolerated and highly immunogenic in men aged 27-45 years who participated in the single-cohort mid-adult male (MAM) study (NCT01432574; n = 150). Here, we report results of a long-term follow up (LTFU) extension of FUTURE III with up to 10 years follow-up.

The Japanese 23-valent pneumococcal polysaccharide vaccine randomized clinical trial: Further reflections on the design and results.

The recent article by Gessner et al. discussed several concerns regarding the design and results of the clinical trial by Maruyama et al. in 2010 on the vaccine efficacy (VE) of 23-valent pneumococcal polysaccharide vaccine.