drugset / Trial / NCT05534035
Booster Superiority Study of PTX-COVID19-B Compared to Vaxzevria® in Adults Aged 18 Years and Older
RandomizedParallel-groupTriple-blindPrevention
Summary
This is a Phase III, Randomized, Observer-Blind Study to Evaluate the Safety and Superiority in Immunogenicity of PTX-COVID19-B Administered as Booster Vaccination Compared to Vaxzevria® in Adults Aged 18 Years and Older Who Were Previously Vaccinated with Vaxzevria®. This study will be a competitive enrollment process in all participating countries. Once the target number of subjects is reached, the enrollment in all participating countries in the particular phase will be stopped.
Timeline
- Start
- 2023-02-03
- Primary completion
- 2023-04-30
- Completion
- 2023-10-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | AZD1222 | Vaccine | 0.5 ml | — |
| Subject | PTX-COVID19-B | Messenger RNA (mRNA) | — | Intramuscular |