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Safety, Reactogenicity, and Immunogenicity Study of a Self-Amplifying MRNA Influenza Vaccine in Healthy Adults

NCT06028347 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-11-27

No results posted yet for this study

Summary

This is a Phase 1, first-in-human, randomized, placebo-controlled, observer blind study. The effect of two doses of an investigational vaccine on safety, reactogenicity, kinetics and magnitude of the post-vaccination antibody response will be evaluated at different timepoints as compared to placebo in healthy adults.

Approximately 96 evaluable subjects will be enrolled in this study; n=72 receiving investigational vaccine and n=24 receiving placebo.

The study has a screening period (Day -28 to Day -1), a treatment period (Day 1 to Day 43) and a follow-up period (Day 44 to Day 202).

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

sa-mRNA vaccine Dose 1

self-amplifying mRNA vaccine

BIOLOGICAL

sa-mRNA vaccine Dose 2

self-amplifying mRNA vaccine

BIOLOGICAL

sa-mRNA vaccine Dose 3

self-amplifying mRNA vaccine

BIOLOGICAL

Placebo

Saline for injection

Sponsors & Collaborators

  • Seqirus

    lead INDUSTRY

Principal Investigators

  • Clinical Program Director · Seqirus

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
2023-10-05
Primary Completion
2024-10-13
Completion
2024-10-13
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT06028347 on ClinicalTrials.gov