drugset
drugset / Trial / NCT05175742

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 ↗

Phase 2 Completed 565 enrolled Providence Therapeutics Holdings Inc.
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator BNT162b2 Messenger RNA (mRNA) — Intramuscular
Subject PTX-COVID19-B Messenger RNA (mRNA) 40 ug Intramuscular

Indications

No indication recorded.