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

NCT06279871 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1514

Last updated 2025-12-12

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

ARCT-2303

Self-Amplifying RNA COVID-19 vaccine (Omicron XBB.1.5)

BIOLOGICAL

Influenza vaccine

Licensed cell-based influenza vaccine

BIOLOGICAL

Influenza vaccine, adjuvanted

Licensed influenza vaccine, adjuvanted

OTHER

Placebo

0.9% saline

Sponsors & Collaborators

  • Seqirus

    collaborator INDUSTRY

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Arcturus Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Program Director · Arcturus Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-27
Primary Completion
2024-10-09
Completion
2024-11-21
FDA Drug
Yes

Countries

  • Australia
  • Costa Rica
  • Honduras
  • Philippines

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06279871 on ClinicalTrials.gov