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PTX-COVID19-B, an mRNA Humoral Vaccine, Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Demonstrate the Safety, Tolerability, and Immunogenicity of PTX-COVID19-B in Comparison to the Pfizer-BioNTech COVID-19 Vaccine.

NCT05175742 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 565

Last updated 2023-04-07

No results posted yet for this study

Summary

The Vaccine Product, PTX-COVID19-B mRNA Humoral Vaccine, is intended for prevention of COVID-19 in a general population. This study is designed to evaluate the safety, tolerability, and immunogenicity of PTX-COVID19-B compared to Pfizer-BioNTech COVID-19 vaccine in healthy seronegative adults aged 18 to 64.

Conditions

  • Covid19 Vaccine

Interventions

BIOLOGICAL

PTX-COVID19-B

Sterile solution for injection

BIOLOGICAL

Pfizer-BioNTech COVID-19 vaccine

Sterile solution for injection

BIOLOGICAL

Placebo

0.9% sodium chloride (normal saline) injection

Sponsors & Collaborators

  • Providence Therapeutics Holdings Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-17
Primary Completion
2023-03-29
Completion
2023-03-29

Countries

  • Canada
  • South Africa

Study Locations

More Related Trials

Entities

Drugs

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 NCT05175742 on ClinicalTrials.gov