Trial Profile
A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX23 Six Months Later in Immunocompetent Adults Between 18 and 49 Years of Age at Increased Risk for Pneumococcal Disease (PNEU - DAY)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 16 May 2022
Price :
$35
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At a glance
- Drugs V 114 (Primary) ; Aluminium phosphate; Pneumococcal 13-valent CRM197 vaccine conjugate; Pneumococcal vaccine
- Indications Pneumococcal infections
- Focus Adverse reactions; Pharmacodynamics; Registrational
- Acronyms PNEU-DAY
- Sponsors Merck Sharp & Dohme Corp.
- 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.
- 16 Jul 2021 According to a Merck & Co media release, based on data from seven studies in 7,438 individuals [NCT03950622, NCT03547167, NCT03480802, NCT03615482 and NCT03480763], the U.S. Food and Drug Administration (FDA) has approved VAXNEUVANCE for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. This application was grated Priority Review by FDA.