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NCT06279871Not yet recruiting

Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults

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
Arcturus Therapeutics, Inc.Phase 3ClinicalTrials.govbiological
Verified
Study focus
Disease/Condition
COVID-19
Drug/Device/Intervention
ARCT-2303
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Arcturus Therapeutics, Inc.
Timeline & enrollment
Phase
Phase 3
Start date
Mar 01, 2024
End date
Dec 01, 2024
Enrollment
1680 participants
Primary outcome

SARS-CoV-2 neutralizing antibody titers,SARS-CoV-2 neutralizing antibody seroconversion rates,Hemagglutination Inhibition (HI) titers,SARS-CoV-2 neutralizing antibody titers

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.

ICD-10 classifications
COVID-19, virus identifiedCOVID-19, virus not identifiedCoronavirus infection, unspecified siteViral infection, unspecifiedRift Valley fever
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06279871
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06279871 through Pure Global AI's free database. This Phase 3 trial is sponsored by Arcturus Therapeutics, Inc. and is currently Not yet recruiting. The study focuses on COVID-19. Target enrollment is 1680 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.