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A Phase IIb, Double-Blind, Randomized, Active Controlled, Multi-center, Non-inferiority Trial to Assess Immunogenicity and Safety of a Booster Vaccination With a Recombinant Protein RBD Fusion Dimer Candidate (PHH-1V) Against SARS-CoV-2, in Adults Fully Vaccinated With Adenovirus Vaccine Against COVID-19

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A Phase IIb, Double-Blind, Randomized, Active Controlled, Multi-center, Non-inferiority Trial to Assess Immunogenicity and Safety of a Booster Vaccination With a Recombinant Protein RBD Fusion Dimer Candidate (PHH-1V) Against SARS-CoV-2, in Adults Fully Vaccinated With Adenovirus Vaccine Against COVID-19

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Mar 2023

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At a glance

  • Drugs PHH-1V (Primary) ; Tozinameran
  • Indications COVID 2019 infections; SARS-CoV-2 acute respiratory disease
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors LABORATORIOS HIPRA

    • Most Recent Events

    • 29 Dec 2022 Status changed from recruiting to completed.
    • 21 Jul 2022 Planned End Date changed from 1 Dec 2022 to 1 Mar 2023.
    • 21 Jul 2022 Planned primary completion date changed from 1 Jun 2022 to 1 Oct 2022.

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