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Booster Study of PTX-COVID19-B in Adults Aged 18 Years and Older

NCT05534048 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3800

Last updated 2022-09-09

No results posted yet for this study

Summary

The purpose of this clinical trial is to Evaluate the Safety and Immunogenicity of PTX-COVID19-B Administered as Booster Vaccination in Previously Vaccinated Adults Aged 18 Years and Older.

This study is seeking participants who are:

Adult males and females 18 years of age or older; In efficacy cohort : Subjects who were previously vaccinated with 2 doses of Comirnaty® administered at least 3 months prior to the booster dose..

All participants in this efficacy cohort will receive 1 of the 2 study vaccines: PTX-COVID19-B or Comirnaty®.

All participants in efficacy cohort will receive a single 40 microgram dose PTX-COVID19-B of the study vaccine or one dose of Comirnaty® at the first study clinic and will return to the study clinic 6 more times. At each clinic visit, a blood sample will be taken. They study is about 6 months long for each participant.

In safety cohort: Subjects who have previously received any primary series approved by WHO Emergency Use Authorization at least 3 months prior to enrollment or subjects who have already received one authorized booster vaccination and planned to receive PTX-COVID19-B as the 4th shot will be enrolled.

All participants in this safety cohort will receive 1 dose vaccines: PTX-COVID19-B.

All participants in safety cohort will receive a single 40 microgram dose of the study vaccine at the first study clinic and will return to the study clinic 5 more times. At each clinic visit, a blood sample will be taken. They study is about 6 months long for each participant.

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

Comirnaty®

0.45 mL concentrate in a 2 mL clear multidose vial (type I glass) with a stopper (synthetic Bromo-butyl rubber) and a purple flip-off plastic cap with aluminum seal. Each vial contains 6 doses.

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
2023-07-02
Completion
2023-12-20

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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 NCT05534048 on ClinicalTrials.gov