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Clinical Trial Summary

This is a multicentre, randomized, observer-blind, active-controlled, superiority, study to compare the immunogenicity of VLA2001 to AZD1222 in terms of GMT. Approximately 4000 participants will be recruited in the study. About 3000 participants aged 30 years and above will be randomized in a 2:1 ratio to receive 2 intramuscular recommended doses of either VLA2001 (n=3000) or AZD1222 (n=1000). In addition, approximately 1000 subjects aged 18-29 years will participate in this study in a non-randomized, open-label fashion to receive VLA2001. The 2 doses of vaccination for both vaccines will be administered 28 days apart, on Days 1 and 29. All visits will be conducted at the clinical site on an outpatient basis.


Clinical Trial Description

This is a multicentre, randomized, observer-blind, active-controlled, superiority, study to compare the immunogenicity of VLA2001 to AZD1222 in terms of GMT. Approximately 4000 participants will be recruited in the study. About 3000 participants aged 30 years and above will be randomized in a 2:1 ratio to receive 2 intramuscular recommended doses of either VLA2001 (n=3000) or AZD1222 (n=1000). In addition, approximately 1000 subjects aged 18-29 years will participate in this study in a non-randomized, open-label fashion to receive VLA2001. The 2 doses of vaccination for both vaccines will be administered 28 days apart, on Days 1 and 29. All visits will be conducted at the clinical site on an outpatient basis. Immunogenicity (neutralizing antibody titers) and safety will be assessed up to months 12 after the first vaccination. Participants will be provided with an electronic Diary (e-Diary) and will be trained to record specifically solicited systemic and local symptoms daily as well as any additional AEs during follow-up period after each of both vaccinations up to the next visit to the site until Day 43 visit has been completed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04864561
Study type Interventional
Source Valneva Austria GmbH
Contact Valneva Clinical Development
Phone +43 1 206 20
Email [email protected]
Status Recruiting
Phase Phase 3
Start date April 26, 2021
Completion date June 30, 2022

See also
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