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A Phase 3, Randomized, Double-blind, Active Comparator-controlled, Multicenter Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Recipients of Allogeneic Hematopoietic Stem Cell Transplant (PNEU-STEM)

Trial Profile

A Phase 3, Randomized, Double-blind, Active Comparator-controlled, Multicenter Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Recipients of Allogeneic Hematopoietic Stem Cell Transplant (PNEU-STEM)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Feb 2019

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-STEM
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 03 Dec 2018 Planned number of patients changed from 250 to 300.
    • 21 Sep 2018 Status changed from not yet recruiting to recruiting.
    • 26 Aug 2018 Planned initiation date changed from 27 Aug 2018 to 10 Sep 2018.
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