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A Parallel-group, Phase III, Multi-stage, Modified Double-blind, Multi-armed Study to Assess the Efficacy, Safety, and Immunogenicity of Two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (Monovalent and Bivalent) for Prevention Against COVID-19 in Adults 18 Years of Age and Older as a Primary Series and Open-label Extension to Assess Immunogenicity, Safety, Efficacy of a Monovalent Booster Dose of SARS-CoV2 Adjuvanted Recombinant Protein Vaccine

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Trial Profile

A Parallel-group, Phase III, Multi-stage, Modified Double-blind, Multi-armed Study to Assess the Efficacy, Safety, and Immunogenicity of Two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (Monovalent and Bivalent) for Prevention Against COVID-19 in Adults 18 Years of Age and Older as a Primary Series and Open-label Extension to Assess Immunogenicity, Safety, Efficacy of a Monovalent Booster Dose of SARS-CoV2 Adjuvanted Recombinant Protein Vaccine

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Oct 2024

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At a glance

  • Drugs SP 0253 (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms VAT00008
  • Sponsors Sanofi Pasteur

Most Recent Events

  • 16 Oct 2024 Status changed from active, no longer recruiting to completed.
  • 03 Jan 2023 Planned End Date changed from 3 Jun 2024 to 31 Jan 2025.
  • 03 Jan 2023 Planned primary completion date changed from 3 Jun 2024 to 31 Jan 2025.

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