A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 18 to 64 years of Age With Increased Risk for Pneumococcal Disease

Pneumococcal infection

Percentage of participants with solicited injection-site adverse events (AEs) from Day 1 through Day 5 postvaccination, Percentage of participants with solicited systemic AEs from Day 1 through Day 5 postvaccination, Percentage of participants with vaccine-related serious adverse events (SAEs) from Day 1 through the duration of participation in the study, Serotype-specific OPA GMTs postvaccination with V116 (30 days postvaccination [Day 30]) or PCV15 + PPSV23 (30 days postvaccination with the final dose in the regimen [Week 12])

Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) postvaccination with V116 (Day 30) and PCV15 + PPSV23 (Week 12), Serotype-specific geometric mean fold rises (GMFRs) from baseline (Day 1) to postvaccination with V116 (Day 30) and from baseline (Day 1) to postvaccination with PCV15 + PPSV2 (Week 12) for OPA responses, Serotype-specific GMFRs from baseline (Day 1) to postvaccination with V116 (Day 30) and from baseline (Day 1) to postvaccination with PCV15 + PPSV23 (Week 12) for IgG responses, Serotype-specific proportion of participants with a ≥4-fold rise from baseline (Day 1) to postvaccination with V116 (Day 30) and from baseline (Day 1) to postvaccination with PCV15 + PPSV2 (Week 12) for OPA responses, Serotype-specific proportion of participants with a ≥4-fold rise from baseline (Day 1) to postvaccination with V116 (Day 30) and from baseline (Day 1) to postvaccination with PCV15 + PPSV2 (Week 12) for IgG responses

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