This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve Japanese adults 65 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 the cross-reactive serotype 15B in V116, and that the immunogenicity of V116 is superior to PPSV23 for the unique serotype 15C in V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in the 8 unique V116 serotypes (except for 15C), 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 AEs (SAEs)
Timeframe: Up to 30 days postvaccination
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Timeframe: Day 30 postvaccination
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116)
Timeframe: Baseline (Day 1) and Day 30 postvaccination