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A Phase 1/2, Randomized, Single Ascending Dose Study in Adults (Stage 1) and Randomized, Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, a Pneumococcal Vaccine

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Trial Profile

A Phase 1/2, Randomized, Single Ascending Dose Study in Adults (Stage 1) and Randomized, Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, a Pneumococcal Vaccine

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 26 Dec 2023

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At a glance

  • Drugs AFX 3772 (Primary) ; Pneumococcal 13-valent CRM197 vaccine conjugate; Pneumococcal vaccine
  • Indications Pneumococcal infections
  • Focus Adverse reactions
  • Sponsors Astellas Pharma Global Development; GSK

Most Recent Events

  • 27 Sep 2023 Number of treatment arms increased from 5 to 9 by the addition of 1 new arm in stage 1 and 3 new arms in stage 2.
  • 08 Jun 2022 Results published in the Vaccine
  • 12 Jul 2021 According to an Affinivax media release, The U.S. Food and Drug Administration (FDA) has also granted Breakthrough Therapy designation for ASP3772 for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes included in ASP3772 in adults aged 50 years and older. The FDA decision is informed by the results of this Phase 2 data.

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