At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Phase 3 Study to Evaluate Safety, Reactogenicity, and Immunogenicity of Co-administration of Ad26.COV2.S and Influenza Vaccines in Healthy Adults 18 Years of Age and Older
In Brief
A Phase 3 clinical trial evaluating Ad26.COV2.S, Placebo, and 1 other intervention for COVID-19 Prevention. Completed, enrolled 861 participants across 31 sites in 3 countries.
Detailed Summary
The purpose of this study is to demonstrate the non-inferiority (NI) of the humoral immune response of the 4 influenza vaccine strains after concomitant administration of the Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of a seasonal quadrivalent standard-dose influenza vaccine administered alone; and to demonstrate the NI of the binding antibody response after concomitant administration of Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of Ad26.COV2.S vaccine administered alone.
Study Details
Timeline
Interventions
Ad26.COV2.S will be administered as an IM injection.
Placebo will be administered as an IM injection.
Influenza vaccine high and standard dose will be administered as IM injection.