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A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

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Trial Profile

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Mar 2024

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At a glance

Most Recent Events

  • 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.
  • 10 Nov 2022 The trial has been completed in Czech Republic (Date of the global end of the trial 2022-08-31) according to European Clinical Trials Database record.

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