Merck: Phase 3 Studies of V114 Vaccine Meet Key Objectives

By Colin Kellaher

Merck & Co. on Wednesday said a pair of Phase 3 studies evaluating V114, its 15-valent pneumococcal conjugate vaccine, met their primary immunogenicity objectives.

The Kenilworth, N.J., drug maker said the results will form the basis of global regulatory licensure applications, beginning with the U.S. Food and Drug Administration, before the end of the year.

Merck said a pivotal 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.

The study also met the key secondary immunogenicity objective, showing superiority of V114 over PCV13 for serotype 3, a leading cause of invasive pneumococcal disease globally, the company said.

Merck said the second study in healthy adults at least 50 years of age met its main immunogenicity objective, showing equivalent immune response across all 15 serotypes for three different lots of V114.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

September 09, 2020 07:25 ET (11:25 GMT)

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