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Phase I/II Study of Quadrivalent Influenza mRNA Vaccines MRT5421, MRT5424, and MRT5429 in Healthy Adults
NCT06361875Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2024
- Primary completion
- Jun 2025
- Countries
- 3
- Sponsor
- Sanofi
- Modality
- Vaccines & Immunotherapeutics, Lipid-based Nanoparticles, mRNA Therapeutics
- Conditions
- influenza
01
Overview
Phase 2 trial of quadrivalent influenza mRNA vaccine MRT5421, quadrivalent influenza mRNA vaccine MRT5424 and MRT5429 in influenza (10 arms), sponsored by Sanofi. Primary endpoints: Number of Participants With Immediate Unsolicited Systemic Adverse Events After Vaccine Administration at 30 months, Number of Participants With Solicited Injection Site Reactions After Vaccine Administration at 7 days and 11 more. Started Apr 2024; status: completed.
02
Design
10 armsQuadrivalent Influenza mRNA Vaccine MRT5421 Dose 1
participants received a single dose of QIV mRNA vaccine MRT5421
Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 1
participants received a single dose of QIV mRNA vaccine MRT5429
Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 2
participants received a single dose of QIV mRNA vaccine MRT5429
Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 3
participants received a single dose of QIV mRNA vaccine MRT5429
Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 4
participants received a single dose of QIV mRNA vaccine MRT5429
Quadrivalent Influenza mRNA Vaccine MRT5424 Dose 1
participants received a single dose of QIV mRNA vaccine MRT5424
4 more in the full profile.
03
Who it enrols
Healthy participants aged 18 years and above. Excludes individuals with known or suspected immunodeficiency, history of myocarditis/pericarditis, Guillain-Barre Syndrome, or recent receipt of other vaccines or blood products.
04
Endpoints
Primary
Number of Participants With Immediate Unsolicited Systemic Adverse Events After Vaccine Administration
Number of Participants With Solicited Injection Site Reactions After Vaccine Administration
Number of Participants With Solicited Systemic Reactions After Vaccine Administration
Number of Participants With Unsolicited Adverse Events After Vaccine Administration
Number of Participants With Medically Attended Adverse Events
Secondary
Geometric Mean of Neutralization Test Antibody Titer
Geometric Mean Ratio of Neutralization Test Antibody Titer
Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer
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