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Clinical Trial Summary

This Phase 3 study is intended to assess clinical lot-to-lot consistency by evaluating and comparing the immunogenicity of three consecutively manufactured lots of Coronavirus-like Particle (CoVLP).


Clinical Trial Description

This is a randomized, observer-blinded, multicenter, Phase 3 lot-to-lot consistency study in approximately 900 healthy seronegative adults 18-49 years of age after the administration of two doses of CoVLP (3.75 ug) adjuvanted with AS03 (referred to as "CoVLP formulation"). Subjects who are seronegative for SARS-CoV-2 antibodies will be randomized in a 1:1:1 ratio to receive one of three lots of the CoVLP formulation. Subjects will receive two intramuscular injections 21 days apart. The same lot will be used for both IM injections in each subject. Safety and immunogenicity assessments will be performed. Subjects will participate in this study for approximately 49 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05040789
Study type Interventional
Source Medicago
Contact Medicago Trial Inquiries
Phone 581-700-1977
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date November 22, 2021
Completion date May 31, 2022

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