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A PHASE 3, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS ≥65 YEARS OF AGE WITH PRIOR PNEUMOCOCCAL VACCINATION

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Trial Profile

A PHASE 3, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS ≥65 YEARS OF AGE WITH PRIOR PNEUMOCOCCAL VACCINATION

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jul 2022

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At a glance

  • Drugs Pneumococcal 20-valent conjugate vaccine (Primary) ; Pneumococcal 13-valent CRM197 vaccine conjugate; Pneumococcal vaccine
  • Indications Pneumococcal infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Pfizer

Most Recent Events

  • 15 Feb 2022 According to a Pfizer media release, European Medicines Agency (EMA) has approved the companys 20-valent pneumococcal conjugate vaccine (PCV20), which will be marketed in the European Union (EU) under the brand name APEXXNAR.The EMA authorization for APEXXNAR is based on evidence from a clinical program in adults, including Phase 1 and 2 trials, and three Phase 3 trials (NCT03760146, NCT03828617, and NCT03835975).
  • 08 Feb 2022 According to a Pfizer media release, the CHMP of the EMA issued a positive opinion recommending the granting of a marketing authorization for the pneumococcal 20-valent conjugate vaccine for the prevention of invasive disease and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes in adults ages 18 years and older.
  • 25 Nov 2021 Results published in the Vaccine

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