This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve adults 50 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23, and that V116 is superior to PPSV23 for the 9 serotypes unique to V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in unique V116 serotypes, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).
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Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
Timeframe: Up to 5 days postvaccination
Percentage of Participants With Solicited Systemic AEs
Timeframe: Up to 5 days postvaccination
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)
Timeframe: Up to 6 months postvaccination
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116
Timeframe: Day 30 postvaccination
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116
Timeframe: Baseline (Day 1) and Day 30 postvaccination