Trial Profile
A Phase 2, Randomized, Double-blind Trial To Evaluate The Safety And Immunogenicity Of A Multivalent Pneumococcal Conjugate Vaccine In Healthy Infants
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 02 May 2023
Price :
$35
*
At a glance
- Drugs Pneumococcal 20-valent conjugate vaccine (Primary) ; Pneumococcal 13-valent CRM197 vaccine conjugate
- Indications Pneumococcal infections
- Focus Adverse reactions; Proof of concept; Registrational
- Sponsors Pfizer
- 27 Apr 2023 According to a Pfizer media release, the U.S FDA has approved PREVNAR 20 for the prevention of invasive pneumococcal disease caused by the 20 Streptococcus pneumoniae serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants 6 weeks through 5 years of age caused by the original seven serotypes contained in PREVNAR, The decision of FDA is based on results from the Phase 2 and Phase 3 clinical trial programs.
- 06 Jan 2023 According to Pfizer media release, The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA on the 20vPnC vaccine application is anticipated in April 2023.
- 06 Jan 2023 According to Pfizer media release, the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for its 20-valent pneumococcal conjugate vaccine candidate for the prevention of invasive pneumococcal disease caused by the 20 Streptococcus pneumoniae serotypes contained in the vaccine in infants and children 6 weeks through 17 years of age and for the prevention of otitis media caused by seven of the 20 Streptococcus pneumoniae seroty