Streptococcus pneumoniae and influenza virus are significant causes of disease worldwide. V114, an investigational 15-valent PCV, contains all serotypes in PCV13 plus serotypes 22F and 33F. This phase 3 trial evaluated safety and immunogenicity of concomitant and non-concomitant administration of V114 and quadrivalent influenza vaccine (QIV) in adults aged ≥50 years.
Overall, 1200 participants were randomized 1:1 to receive either V114 administered concomitantly with QIV (concomitant group) or V114 administered 1 month after QIV (non-concomitant group); randomization was stratified by age and history of prior pneumococcal polysaccharide vaccine. Pneumococcal serotype-specific opsonophagocytic activity (OPA) and influenza strain-specific hemagglutination inhibition (HAI) antibodies were measured prior and 30 days postvaccination. Demonstration of non-inferior immunogenicity between the concomitant and non-concomitant group required the lower bound of the 95% confidence interval of the ratio of OPA and HAI geometric mean titers (GMTs) to be ≥0.5.
Proportions of participants reporting any AE, injection-site AEs, and systemic AEs were generally comparable between vaccination groups. Non-inferiority was demonstrated for all 15 pneumococcal serotypes and all 4 influenza strains between vaccination groups.
V114 administered concomitantly with QIV was generally well tolerated and immunologically non-inferior to non-concomitant administration, supporting co-administration of both vaccines.