Merck unveils results from Phase 2 trial of V114 vaccine in infants
Category: #health  By Sunil Hebbalkar  Date: 2019-05-10
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Merck unveils results from Phase 2 trial of V114 vaccine in infants

V114 has secured a Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) to avert invasive pneumococcal disease (IPD) in January 2019.

The U.S. based multinational pharmaceutical company Merck, also known as MSD outside Canada and the United States, has reportedly announced the results from a Phase 2 trial evaluating the immunogenicity, safety, and tolerability of V114. The experimental 15-valent pneumococcal conjugate vaccine of the company, in comparison with the currently available 13-valent pneumococcal conjugate vaccine (PCV13) in healthy infants 6-12 weeks of age.

Reportedly, in the trial, selected V114-008, V114 intersected its primary endpoint for the 13 serotypes contained in both the vaccines by indicating noninferiority. V114 also brought on an immune reaction in newborns for two additional serotypes, 22F and 33F, causing diseases.  These serotypes are not contained in PCV13.

V114 has secured a Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) to avert invasive pneumococcal disease (IPD) in January 2019. IPD is triggered in pediatric patients aging from 6 weeks to 18 years by the vaccine serotypes. The decision of FDA was partially informed by immunogenicity data from this Phase 2 study, the Phase 1/2 V114-005 study and V114-008 in healthy adults and infants. The outcomes of the V114-008 study were shown during an oral session at the 37thAnnual Meeting of the European Society for Pediatric Infectious Diseases (ESPID) in Ljubljana, Slovenia, and strengthen continued progression of Phase 3 clinical studies with V114.

V114-008, a double-blind, randomized, Phase 2 trial, compared the tolerability, immunogenicity, and safety of two distinct clinical lots of V114 (n=350 for lot 1; n=347 for lot 2) to PCV13 (n=347) in around 1,050 healthy infants aging two, four, six and 12-15 months. In the study, the percentage of subjects attaining the upper limit of immune reaction (IgG≥0.35 mcg/mL) accepted by WHO with lot of V114 was noninferior to the percentage observed with PCV13 for the 13 serotypes shared between the two vaccines.

Source credit: https://www.businesswire.com/news/home/20190508005210/en/Merck-Announces-Results-Phase-2-Trial-Investigational

https://www.mrknewsroom.com/news-release/research-and-development-news/merck-announces-results-phase-2-trial-investigational-15-



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Sunil Hebbalkar

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Sunil Hebbalkar

Sunil Hebbalkar develops content for Algosonline, Market Size Forecasters, and a couple of other platforms. A Post graduate mechanical design engineer by qualification, he worked as an intern at the defense lab for one year in the engine design and development departm...

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