A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above
Phase 1/2
Completed
NCT06361875
| Condition | Influenza Immunization, Healthy Volunteers |
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| Phase | Phase 1/2 |
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| Sponsor | Sanofi Pasteur, a Sanofi Company |
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| Status | Completed |
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| Enrollment | 908 participants |
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| Interventions | Quadrivalent Influenza mRNA Vaccine MRT5421, Quadrivalent Influenza mRNA Vaccine MRT5424, Quadrivalent Influenza mRNA Vaccine MRT5429, Quadrivalent Influenza Standard Dose Vaccine, Quadrivalent Influenza High-Dose Vaccine |
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| Start date | Apr 1, 2024 |
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| Completion date | Jun 9, 2025 |
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| Results posted | Aug 4, 2026 |
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Summary
The purpose of this study was to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different formulations of Quadrivalent Influenza Vaccine (QIV) messenger ribonucleic acid (mRNA) (MRT5421, MRT5424, and MRT5429) compared to an active control (QIV- standard dose (SD), QIV- high dose (HD) \[adults ≥ 65 years of age only\], or quadrivalent recombinant influenza vaccine (RIV4)) in adults 18 years of age and older.
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) After Vaccine Administration
Within 30 minutes after vaccine administration on Day 1 · Participants
| QIV mRNA LNP 1: 30 mcg | 1 Participants |
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| QIV mRNA LNP 1: 96 mcg | 1 Participants |
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| QIV mRNA LNP 1: 132 mcg | 1 Participants |
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| QIV mRNA LNP 1: 192 mcg | 0 Participants |
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| QIV mRNA LNP 2: 96 mcg | 1 Participants |
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| QIV mRNA LNP 2: 192 mcg | 0 Participants |
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Number of Participants With Solicited Injection Site Reactions After Vaccine Administration
Within 7 days after vaccine administration on Day 1 · Participants
| QIV mRNA LNP 1: 30 mcg | 11 Participants |
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| QIV mRNA LNP 1: 96 mcg | 71 Participants |
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| QIV mRNA LNP 1: 132 mcg | 76 Participants |
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| QIV mRNA LNP 1: 192 mcg | 79 Participants |
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| QIV mRNA LNP 2: 96 mcg | 74 Participants |
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| QIV mRNA LNP 2: 192 mcg | 17 Participants |
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Number of Participants With Solicited Systemic Reactions After Vaccine Administration
Within 7 days after vaccine administration on Day 1 · Participants
| QIV mRNA LNP 1: 30 mcg | 15 Participants |
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| QIV mRNA LNP 1: 96 mcg | 58 Participants |
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| QIV mRNA LNP 1: 132 mcg | 71 Participants |
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| QIV mRNA LNP 1: 192 mcg | 73 Participants |
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| QIV mRNA LNP 2: 96 mcg | 60 Participants |
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| QIV mRNA LNP 2: 192 mcg | 18 Participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.