This Phase 3 study is designed to evaluate the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the Pneumococcal Conjugate Vaccine (PCV) immunization schedule.
Participants were randomized to one of five vaccination groups receiving a complete 4-dose schedule with PCV13, one of three mixed 4-dose schedules with PCV13 followed by V114, or a complete 4-dose schedule with V114. Immune responses for the 13 shared serotypes contained in V114 and PCV13 were measured at 30 days post-dose four (PD4) and compared between the groups receiving mixed PCV13/V114 schedules and the group receiving a complete PCV13 schedule. Immune responses were assessed based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs).
Results of the primary immunogenicity analyses demonstrated that the IgG GMCs for the 13 shared serotypes at 30 days PD4 were generally comparable between participants administered mixed dosing schedules with PCV13/V114 and participants administered a complete dosing schedule with PCV13.
Safety analyses were performed on the All-Participants-As-Treated (APaT) population, defined as all randomized participants who received at least one dose of study vaccination, and showed comparable safety profiles across the five vaccination groups.