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A PHASE 3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BNT162b2 (LP.8.1)-ADAPTED VACCINE IN CHILDREN 5 THROUGH 11 YEARS OF AGE CONSIDERED AT HIGH RISK FOR SEVERE COVID-19

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Trial Profile

A PHASE 3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BNT162b2 (LP.8.1)-ADAPTED VACCINE IN CHILDREN 5 THROUGH 11 YEARS OF AGE CONSIDERED AT HIGH RISK FOR SEVERE COVID-19

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Feb 2026

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At a glance

  • Drugs Tozinameran (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors BioNTech

Most Recent Events

  • 11 Feb 2026 Planned End Date changed from 30 Oct 2026 to 31 Jul 2026.
  • 11 Feb 2026 Planned primary completion date changed from 30 Oct 2026 to 31 Jul 2026.
  • 11 Feb 2026 Status changed from recruiting to active, no longer recruiting.

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