A phase 3, randomized study to evaluate the safety, tolerability, and immunogenicity of V116 in children and adolescents with increased risk of pneumococcal disease (STRIDE-13).

Pneumococcal disease (PD) causes significant illness and death, especially in young children, older adults, and individuals with chronic medical conditions. Due to increased risk, children with chronic conditions are often advised to receive additional pneumococcal vaccination beyond the routine primary series. This phase 3 study evaluated the safety and immunogenicity of V116, a 21-valent pneumococcal conjugate vaccine, compared to PPSV23 in children aged 2 to <18 y with certain medical conditions that increase risk of PD who had previously completed a primary pneumococcal vaccination regimen. Individuals with diabetes mellitus, chronic heart, chronic lung, chronic kidney, and/or chronic liver disease were randomized 3:2 to receive a single dose of either V116 (n = 531) or PPSV23 (n = 351). Immunogenicity was assessed at 30 d postvaccination comparing opsonophagocytic activity (OPA) geometric mean titers (GMTs) and immunoglobulin G (IgG) geometric mean concentrations (GMCs) between groups. Safety was evaluated by the proportion of participants with adverse events (AEs). The V116 group met the statistical noninferiority criterion for each of the 12 pneumococcal vaccine serotypes shared between V116 and PPSV23 and additionally met superiority criterion for each of the 9 serotypes unique to V116 based on OPA GMTs. IgG GMCs were consistent with the OPA results. The safety profile was generally comparable between groups. In children and adolescents aged 2 to <18 y with certain medical conditions, V116 is well tolerated and immunogenic. These findings support the use of V116 to broaden pneumococcal serotype coverage in populations at increased risk of pneumococcal disease.