Merck V114 Vaccine Meets Primary Endpoint in Phase 2 Study
08 Mai 2019 - 3:56PM
Dow Jones News
By Colin Kellaher
Merck & Co. (MRK) on Wednesday said a phase 2 study of V114,
its investigational 15-valent pneumococcal conjugate vaccine in
infants six to 12 weeks of age, met its primary endpoint.
The Kenilworth, N.J., drug maker said V114 showed noninferiority
to PCV13, the currently available 13-valent vaccine, for the 13
serotypes contained in both vaccines.
V114 also induced an immune response in infants for two
additional disease-causing serotypes not contained in PCV13, the
company added.
Merck said the data support continued progression of its phase 3
studies of V114. The company's V114 development program currently
comprises 11 phase 3 trials.
Merck in January received breakthrough-therapy designation from
the U.S. Food and Drug Administration for V114 for the prevention
of invasive pneumococcal disease in pediatric patients six weeks to
18 years of age.
The FDA's breakthrough-therapy designation aims to expedite the
development and review of a drug for serious conditions when
preliminary clinical evidence shows the drug may show substantial
improvement over available therapies.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 08, 2019 09:41 ET (13:41 GMT)
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