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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 email@example.com
(END) Dow Jones Newswires
May 08, 2019 09:41 ET (13:41 GMT)
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