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

NCT05534035 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2022-09-09

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Everest Medicines (Singapore) Pte. Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-03
Primary Completion
2023-04-30
Completion
2023-10-18

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05534035 on ClinicalTrials.gov