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

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Apr 2024

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At a glance

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

    • Most Recent Events

    • 09 Apr 2024 I feel overseas phase 3 study is a long name of study.
    • 26 Mar 2024 According to Pfizer media release, based on the results of a domestic phase 3 study in infants and an overseas phase 3 study, the company obtained manufacturing and marketing approval for Prevenar 20 in Japan for the prevention of sexually transmitted diseases.
    • 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).

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