Merck: Phase 3 Studies of V114 Vaccine Meet Key Objectives
September 09 2020 - 7:40AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 09, 2020 07:25 ET (11:25 GMT)
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