Clinical Trial

Study of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults

Active, Not Recruiting Phase 2/3
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Summary
This Phase 2/3 study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP has an acceptable immunogenicity and safety profile. The Phase 3 portion is an event-driven, randomized, observer blinded, placebo-controlled design that will evaluate the efficacy and safety of the CoVLP formulation compared to placebo. Subjects will be followed for safety and immunogenicity for a period of 12 months after the last vaccination.
Protocol Amendment History 25 amendments
This ClinicalTrials.gov record has been amended 25 times since 2020-11-18; most recent amendment 2024-04-08.
Status change: Active, Not Recruiting → Completed 2022-10-30
Status change: Recruiting → Active, Not Recruiting 2021-09-07
Status change: Not Yet Recruiting → Recruiting 2020-11-27
Trial Details
NCT Number NCT04636697
Lead Sponsor Medicago
Conditions SARS-CoV-2 Infection
Enrollment 30,918 participants
Start Date 2020-11-19
Primary Completion 2021-08-25 (estimated)
Study Completion 2022-04-30 (estimated)
Updated on ClinicalTrials.gov 2022-04-06