MRK Merck and Co Inc

By Chris Wack

Merck & Co. Inc. said V114, its investigational 15-valent pneumococcal conjugate vaccine, met its primary immunogenicity and safety endpoints in two trials of its Phase 3 pediatric clinical program.

The company said the data supports the potential use of V114 in healthy infants who may have previously started a pneumococcal vaccination series with the currently available 13-valent pneumococcal conjugate vaccine, and in a catch-up setting for healthy children who were either pneumococcal vaccine-naive or who previously received a full or partial regimen with lower valency pediatric pneumococcal conjugate vaccines.

In the first interchangeability study in healthy infants 42-90 days of age, immune responses in those who received a four-dose series of PCV13, and those who received a mixed dose schedule of PCV13 followed by V114, were generally comparable for the 13 serotypes, or strains of pneumococcal disease, targeted by both vaccines.

In the catch-up study, Merck said immune responses were generally comparable to PCV13 for the 13 shared serotypes when V114 was used as a catch-up regimen in healthy children 7 months to 17 years of age who were either pneumococcal vaccine-naive or who previously received a partial or full regimen of a licensed pediatric PCV.

In each study, V114 was generally well-tolerated, with a safety profile comparable to PCV13, it said.

The V114 Phase 3 clinical development program is comprised of 16 trials investigating the safety, tolerability and immunogenicity of V114 in a variety of populations who are at increased risk for pneumococcal disease including healthy older adults and children, as well as people who are immunocompromised or have certain chronic medical conditions.

Merck said plans are on track for submission of a supplemental regulatory licensure application to the U.S. Food and Drug Administration for use in children before the end of the year, pending action on the adult Biologics Licensure Application currently under FDA review.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

May 20, 2021 07:14 ET (11:14 GMT)

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