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About
This is a multicenter, observer-blind, randomized, controlled phase 3 study to evaluate the immunogenicity, reactogenicity, and safety of an investigational self-amplifying RNA COVID-19 vaccine (ARCT-2303) administered concomitantly with quadrivalent influenza vaccines or standalone in adults who previously received authorized COVID-19 vaccine.
Full description
Approximately 1680 participants previously vaccinated with authorized COVID-19 vaccine will be enrolled in this study in two age cohorts (younger adults and older adults). Within each cohort, participants will be randomly assigned in a ratio of 1:1:1 to receive the ARCT-2303 vaccine concomitantly with a quadrivalent influenza vaccine, the ARCT-2303 vaccine and placebo, or the quadrivalent influenza vaccine and placebo. The assessment of immunogenicity will be performed 28 days after vaccination. To provide equal benefit from the participation in the study and complete seasonal vaccination against COVID-19 and influenza, a switchover vaccine dose (influenza, ARCT-2303 or placebo) will be administered 28 days after initial vaccination. All participants will be followed up for safety assessment until the end of the study.
A historical control group vaccinated on a similar schedule (ARCT-154 vaccine) from a previous study (ARCT-154-J01) will be used to compare with the immunogenicity of the ARCT-2303 vaccine.
Cohort A (younger adults; approximately 1200 participants):
Cohort B (older adults; approximately 480 participants):
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
1, Individuals are male, female, or transgender adults ≥18 years of age.
Healthy participants or participants with pre-existing stable medical conditions.
Participant or legally authorized representatives must freely provide documented informed consent prior to study procedures being performed.
Individuals must have been previously vaccinated with COVID-19 vaccines.
Individuals of childbearing potential must be willing to adhere to contraceptive requirements.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
1,680 participants in 6 patient groups
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Central trial contact
Clinical Trial Disclosure Manager
Data sourced from clinicaltrials.gov
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