PNEU-PLAN is a Phase 3, multicenter, randomized, double-blind, active comparator-controlled, descriptive study to evaluate the safety, tolerability, and immunogenicity of catch-up vaccination regimens of V114 in healthy infants, children, and adolescents 7 months to 17 years of age (n=606).
Randomization will be stratified by age (7 months to 11 months, 12 months to 23 months [<2 years], ≥2 years to <6 years, and ≥6 years to 17 years [inclusive]).
The primary objectives are to evaluate the safety and tolerability of V114 and to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following the last dose for each vaccination group. There is no formal hypothesis.
Participants who were either pneumococcal vaccine-naïve or who previously received a partial or full regimen of licensed pediatric PCV were randomized to receive either V114 or PCV13.
Participants received a three, two or one dose regimen of V114 depending on their age cohort at randomization. The three age cohorts were children 7 to 11 months of age (three dose regimen), 12 to 23 months of age (two dose regimen) and 2 to 17 years of age (one dose regimen). Immune responses for the 13 shared serotypes contained in V114 and PCV13 and the two serotypes unique to V114 were measured at 30 days post final vaccination. Immunogenicity comparisons were assessed based on anti-PNPs serotype specific IgG GMCs.
Results of the primary immunogenicity analyses demonstrated that the IgG GMCs for the 13 shared serotypes 30 days post final vaccine were generally comparable between groups for each of the three cohorts, and higher in V114 groups for serotypes 22F and 33F, the two serotypes included in V114 but not PCV13.
Results of the safety analyses demonstrated that V114 was generally well-tolerated with a safety profile comparable to PCV13.