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A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults 50 Years of Age or Older (PNEU-TRUE)

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults 50 Years of Age or Older (PNEU-TRUE)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 May 2022

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At a glance

  • Drugs V 114 (Primary) ; Pneumococcal 13-valent CRM197 vaccine conjugate
  • Indications Pneumococcal infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Acronyms PNEU-TRUE
  • Sponsors Merck Sharp & Dohme Corp.

Most Recent Events

  • 13 Jan 2022 Results published in the Vaccine
  • 12 Jan 2021 According to a Merck and Co media release, additional studies in the BLA support the potential use of V114 in various real-world clinical settings, including in co-administration with the quadrivalent influenza vaccine and as part of a sequential administration with PNEUMOVAX 23, and demonstrate equivalent performance among consecutive lots of V114.
  • 12 Jan 2021 According to a Merck and Co media release, the company looks forward to working with the FDA during the review of this application.The BLA and priority review designation are supported by results from Phase 2 and Phase 3 clinical studies in a variety of adult populations, including healthy adults and those at increased risk, such as adults with chronic medical conditions, adults with HIV, and those 65 years of age and older.

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