This Phase 1 and Phase 2 study will evaluate the safety, tolerability, and immunogenicity of V116 when administered to adults.

The primary hypotheses for Phase 2 are: V116 is noninferior to Pneumovax™23 as measured by the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for the common serotypes at 30 days post-vaccination and that the serotype-specific OPA GMTs for the unique serotypes in V116 at 30 days post-vaccination are statistically significantly greater following vaccination with V116 than those following vaccination with Pneumovax™23.

Results

This clinical trial evaluated V116 in pneumococcal vaccine-naïve adults 18-49 years of age (Phase 1) and 50 years of age and older (Phase 2).

V116 met the primary immunogenicity objectives in both populations and was well-tolerated with an overall safety profile comparable to PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) across age groups.

In the Phase 2 part of the study, V116 demonstrated non-inferior immune responses to PNEUMOVAX 23 for all shared serotypes and superior immune responses for the serotypes included in V116 but not included in PNEUMOVAX 23, based on study-defined criteria.