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COVID-19 booster immunogenicity trial comparing Comirnaty with adjuvanted Sanofi/GSK subunit boosters
2021-004550-33Phase 3Completed
- Sponsor
- Assistance publique - Hôpitaux de Paris
- Start
- Sep 2021
- Modality
- Vaccines & Immunotherapeutics, mRNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 3, randomised, single-blind trial in coronavirus disease 2019 (COVID-19) comparing Comirnaty booster, Sanofi/GSK CoV2 preS dTM-AS03 booster (D614) and Sanofi/GSK CoV2 preS dTM-AS03 booster (B.1.351) (3 arms). Primary endpoint: At least 10-fold increase in neutralizing antibody titers from Day 0 to Day 28. Started Sep 2021; status: completed.
02
Drugs
tozinameranSARS-CoV-2 recombinant protein vaccine monovalent D614 + AS03 adjuvantCoV2 preS dTM-AS03 adjuvanted vaccine (B.1.351)
03
Conditions
coronavirus disease 2019 (COVID-19)
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