This study was designed to evaluate the safety and tolerability of a single dose of V114 when administered concomitantly and non-concomitantly (i.e., 30 days after) with influenza vaccine.

It also evaluated whether V114 can be administered concomitantly with influenza vaccine without impairing the antibody response to the 15 serotypes contained in V114 and to the 4 influenza viruses contained in the seasonal inactivated quadrivalent influenza vaccine (QIV).

The primary hypotheses state that immune responses to V114 and to QIV are non-inferior when administered concomitantly as compared with non-concomitant administration as measured by serotype-specific opsonophagocytic activity (OPA) and hemagglutination inhibition (HAI) geometric mean titers (GMTs) at 30 days postvaccination.

This study will also contribute to the overall safety database and immunogenicity data for V114 to support initial licensure in adults.

Results

Results from the PNEU-FLU (V114-021) study in healthy adults 50 years of age or older showed that V114 can be given concomitantly with the quadrivalent influenza vaccine. These data, in addition to results from V110-029, a study evaluating PNEUMOVAX ® 23 (Pneumococcal Vaccine Polyvalent) in healthy adults 50 years of age or older, were published via the International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD)