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Immunogenicity and Reactogenicity Following a 3rd Dose of COVID-19 mRNA Vaccine (Pfizer-BioNtech) and Two Adjuvanted Sub-unit Vaccines (SP/GSK) Administered as a Booster in Adults Who Received 2 Doses of Pfizer-BioNTech mRNA Vaccine as a Primary Vaccination: A Randomized, Single-blinded Multicenter Clinical Trial

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Trial Profile

Immunogenicity and Reactogenicity Following a 3rd Dose of COVID-19 mRNA Vaccine (Pfizer-BioNtech) and Two Adjuvanted Sub-unit Vaccines (SP/GSK) Administered as a Booster in Adults Who Received 2 Doses of Pfizer-BioNTech mRNA Vaccine as a Primary Vaccination: A Randomized, Single-blinded Multicenter Clinical Trial

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Oct 2023

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At a glance

  • Drugs SP 0253 (Primary) ; Tozinameran (Primary)
  • Indications COVID 2019 infections
  • Focus Pharmacodynamics; Registrational
  • Acronyms COVIBOOST

Most Recent Events

  • 07 Sep 2023 Status changed from active, no longer recruiting to completed.
  • 21 Dec 2022 According to a GlaxoSmithKline media release, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has authorized SARS-CoV-2 spike protein (B.1.351 strain) vaccine for the prevention of COVID-19 disease in adults aged 18 and above in Great Britain based on data from the VAT00013 and VAT00002 trials.
  • 21 Dec 2022 According to a Sanofi media release, The Medicines and Healthcare products Regulatory Agency (MHRA) has authorized Sanofis SARS-CoV-2 spike protein (B.1.351 strain) vaccine for the prevention of COVID-19 disease in adults aged 18 and above in Great Britain, following the European Commission license last month which included Northern Ireland, The approval is based on results from two separate immunogenicity trials, including one comparative trial with an approved mRNA booster as a comparator.

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