Trial Profile
A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 20 Dec 2022
Price :
$35
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At a glance
- Drugs Hepatitis B vaccine recombinant (Primary) ; Hib vaccine conjugate (Primary) ; Hib-DTaP-poliovirus vaccine (Primary) ; Measles mumps and rubella virus vaccine (Primary) ; Pneumococcal 13-valent CRM197 vaccine conjugate (Primary) ; Rotavirus W179-9 vaccine (Primary) ; V 114 (Primary) ; Varicella zoster virus vaccine live (Primary)
- Indications Pneumococcal infections
- Focus Adverse reactions; Pharmacodynamics
- Acronyms PNEU-DIRECTION
- Sponsors Merck Sharp & Dohme
- 13 Dec 2022 Results evaluating safety and immunogenicity of mixed PCV13/V114 regimens, published in the Vaccine
- 22 Jun 2022 According to a Merck & Co media release, the U.S. Food and Drug Administration (FDA) has approved an expanded indication for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) to include children 6 weeks through 17 years of age. The approval follows the FDA's Priority Review of Merck's supplemental application. This approval based on data from seven trials including NCT03893448, NCT03620162, NCT03885934.
- 20 May 2021 According to a media release, full results from PNEU-DIRECTION will be presented at a future scientific congress