drugset / Trial / NCT05534035

Booster Superiority Study of PTX-COVID19-B Compared to Vaxzevria® in Adults Aged 18 Years and Older

NCT05534035

Phase 3 Unknown 450 enrolled Everest Medicines (Singapore) Pte. Ltd.
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

EvaluationDrugModalityDoseRoute
Comparator AZD1222 Vaccine 0.5 ml
Subject PTX-COVID19-B Messenger RNA (mRNA) Intramuscular

Indications