Trial Profile
A PHASE 3, SINGLE-ARM TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHILDREN 15 MONTHS THROUGH 17 YEARS OF AGE
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 15 Mar 2024
Price :
$35
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At a glance
- Drugs Pneumococcal 20-valent conjugate vaccine (Primary)
- Indications Pneumococcal infections
- Focus Adverse reactions; Pharmacodynamics; Registrational
- Sponsors Pfizer
- 13 Mar 2024 According to a Pfizer media release, the authorization follows the recent positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The EC authorization of PREVENAR 20 is based on evidence from the Phase 3 clinical trial program comprised of four core pediatric studies (NCT04546425, NCT04382326, NCT04379713, NCT04642079).
- 13 Mar 2024 According to a Pfizer media release, company announced that the European Commission (EC) has granted marketing authorization for the company's 20- valent pneumococcal conjugate vaccine, marketed in the European Union under the brand name PREVENAR 20, for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age.
- 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.