Merck announces its investigational 15-valent pneumococcal conjugate vaccine V114 met safety and immunogenicity objectives in initial phase III studies in adults

PNEU-WAY (V114-018) study in adults with HIV showed V114 elicited immune response to all 15 serotypes included in vaccine, including 22F and 33F. The PNEU-FLU (V114-021) study in healthy adults age ≥50 years showed V114 can be given concomitantly with quadrivalent flu vaccine.

SPS commentary:

V114 consists of pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and includes serotypes 22F and 33F, which are commonly associated with invasive pneumococcal disease worldwide and are not contained in the pneumococcal conjugate vaccine currently licensed for use in adults. The company plans to continue to work with FDA and other regulatory authorities around the world on filing plans for licensing of this vaccine as additional data from the phase III program become available.


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