drugset / Trial / NCT05749926
Immunogenicity and Reactogenicity of the Beta-variant Recombinant Protein Booster Vaccine (VidPrevtyn Beta, Sanofi) Compared to a Bivalent mRNA Vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in Adults Previously Vaccinated With at Least 3 Doses of COVID-19 mRNA Vaccine
Phase 3
Unknown
248 enrolled
Assistance Publique - Hôpitaux de Paris
IREIVAC/COVIREIVAC Network · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
The objective of this trial is to compare the immunogenicity and the safety of the Beta-variant recombinant protein booster vaccine (VidPrevtyn® Beta, Sanofi) to a bivalent mRNA vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in adults previously vaccinated with at least 3 doses of COVID-19 mRNA vaccine. The results will provide important data for the future COVID 19 vaccine strategy. A biobank will also be set up to evaluate the protection conferred by one or other of these vaccines as booster in the event of the emergence of new variants in the future.
Timeline
- Start
- 2023-05-16
- Primary completion
- 2023-07-12
- Completion
- 2024-07-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | BNT162b2 | Messenger RNA (mRNA) | — | — |
| Subject | VidPrevtyn Beta | Protein / enzyme biologic | — | — |