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Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in Adults

NCT06125691 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2025-10-03

No results posted yet for this study

Summary

This is a safety and Immunogenicity first-in-human dose-ranging study of self-amplifying RNA Seasonal Influenza Vaccine (ARCT-2138) in adults.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

ARCT-2138

Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle.

BIOLOGICAL

Licensed Quadrivalent Vaccine for younger adults

Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle.

BIOLOGICAL

Licensed Quadrivalent Vaccine for older adults

Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle.

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
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-22
Primary Completion
2024-08-10
Completion
2025-01-07

Countries

  • Australia

Study Locations

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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 NCT06125691 on ClinicalTrials.gov