At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of a Self-Amplifying RNA COVID-19 Vaccine (ARCT-2303), Administered Concomitantly With Quadrivalent Influenza Vaccines, in Adults
In Brief
A Phase 3 clinical trial evaluating ARCT-2303, Influenza vaccine, and 2 other interventions for COVID-19. Completed, enrolled 1,514 participants across 29 sites in 4 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Self-Amplifying RNA COVID-19 vaccine (Omicron XBB.1.5)
Licensed cell-based influenza vaccine
Licensed influenza vaccine, adjuvanted
0.9% saline