NCT05534035

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

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®

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Everest Medicines (Singapore) Pte. Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	PTX-COVID19-B	The vaccine product, PTX-COVID19-B, is a preservative-free, sterile mRNA-lipid nanoparticle (mRNA-LNP) dispersion in an aqueous cryoprotectant buffer intended for IM injection.
BIOLOGICAL	Vaxzevria®	The AstraZeneca COVID-19 Vaccine is a colorless to slightly brown solution, clear to slightly opaque with a pH of 6.6. One dose (0.5 ml) contains: COVID-19 Vaccine (ChAdOx1-S\* recombinant) 5 × 1010 viral particles (vp) (corresponding to not less than 2.5 × 108 ifu).

Timeline

• Start date: 2023-02-03
• Primary completion: 2023-04-30
• Completion: 2023-10-18
• First posted: 2022-09-09
• Last updated: 2022-09-09