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Merck Reports Positive Topline Results From Two Adult Studies Evaluating V114

Merck (MRK) said two phase 3 adult studies evaluating the safety, tolerability and immunogenicity of V114 met their primary immunogenicity objectives. V114 is Merck's investigational 15-valent pneumococcal conjugate vaccine in phase 3 development for the prevention of pneumococcal disease in adults and children.

In both studies, V114 was generally well tolerated. The company said these findings, and additional phase 3 data, will form the basis of global regulatory licensure applications, beginning with the FDA, before the end of the year.

The pivotal PNEU-AGE (V114-019) study in healthy adults 50 years of age or older showed that V114 is non-inferior to the currently available 13-valent pneumococcal conjugate vaccine for the 13 serotypes targeted by both vaccines and superior for serotypes 22F and 33F, the two serotypes targeted by V114 but not PCV13.

In another phase 3 study, PNEU-TRUE (V114-020), in healthy adults 50 years of age or older, V114 met its primary immunogenicity objective showing equivalent immune response across all 15 serotypes for three different lots of V114.

Roy Baynes, chief medical officer, Merck Research Laboratories, said: "These phase 3 data demonstrated that V114 generated a robust immune response to all 15 serotypes included in the vaccine and reinforce the potential for this investigational vaccine to help protect adults against pneumococcal disease."

The V114 phase 3 clinical development program is comprised of 16 trials investigating the safety, tolerability and immunogenicity of V114 in a variety of populations.

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