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)
Phase of Trial: Phase III
Latest Information Update: 07 Dec 2019
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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-STEM
- Sponsors Merck Sharp & Dohme
- 03 Apr 2019 Planned End Date changed from 27 Feb 2021 to 10 Nov 2021.
- 03 Apr 2019 Planned primary completion date changed from 27 Feb 2021 to 10 Nov 2021.
- 03 Dec 2018 Planned number of patients changed from 250 to 300.