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A Phase 3, Multicenter, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVA 23 One Year Later in Healthy Adults 50 Years of Age or Older (PNEU-PATH)

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A Phase 3, Multicenter, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVA 23 One Year Later in Healthy Adults 50 Years of Age or Older (PNEU-PATH)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 May 2022

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At a glance

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

    • Most Recent Events

    • 15 Dec 2021 According to a Merck KGaA media release, based on data from seven studies in 7,438 individuals, the European Commission (EC) has approved VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.
    • 15 Oct 2021 According to a Merck KGaA media release, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older, based on data from seven studies in 7,438 individuals and a final decision is expected by the end of the year.
    • 03 Sep 2021 Results published in the Vaccine

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