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A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN AS A SERIES OF 2 INFANT DOSES AND 1 TODDLER DOSE IN HEALTHY INFANTS

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Trial Profile

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN AS A SERIES OF 2 INFANT DOSES AND 1 TODDLER DOSE IN HEALTHY INFANTS

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Nov 2025

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At a glance

  • Drugs Pneumococcal 20-valent conjugate vaccine (Primary) ; Hib DTaP hepatitis B poliovirus vaccine (Infanrix hexa); Measles virus vaccine live; Pneumococcal 13-valent CRM197 vaccine conjugate; Varicella zoster virus vaccine live
  • Indications Pneumococcal infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Pfizer

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.
  • 27 Apr 2023 According to a Pfizer media release, in November 2022, company submitted the 20-valent pneumococcal conjugate vaccine candidate pediatric indication to the European Medicines Agency (EMA).

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