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NCT05553301 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older
A Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 560
- Enrollment target
NCT05553301: Completed Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT05553301 is a Phase 1 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 560 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (833% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05553301, a Phase 1 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 560 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of up to 2 dose levels of Quadrivalent Influenza messenger ribonucleic acid (mRNA) Vaccine MRT5407 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.
Primary Outcome
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Interventions
- BIOLOGICAL Quadrivalent Influenza Standard Dose Vaccine
- BIOLOGICAL Quadrivalent Recombinant Influenza Vaccine
- BIOLOGICAL Quadrivalent Influenza mRNA Vaccine MRT5407
- BIOLOGICAL Quadrivalent Influenza High-Dose Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 560 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2024-01-19 |
| Phase | Phase 1 |
What the finished NCT05553301 record still lists
NCT05553301 is an interventional study that assigns participants to a tested intervention. The registered 560 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (833% higher).
The record links to 0 conditions, and to 4 interventions - of which Quadrivalent Influenza Standard Dose Vaccine is the first listed.
NCT05553301 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05553301 about?
NCT05553301 is a clinical study titled "Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older". The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of up to 2 dose levels of Quadrivalent Influenza messenger ribonucleic acid (mRNA) Vaccine MRT5407 compared to an active control (QIV standard-dose (SD), QIV high-dose (HD) \[adults ≥ 65 y...
What is the current status of trial NCT05553301?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 560 participants. The study started on 2022-10-03. Estimated completion is 2024-01-19.
What interventions are being tested in trial NCT05553301?
The interventions under investigation include: Quadrivalent Influenza Standard Dose Vaccine (BIOLOGICAL), Quadrivalent Recombinant Influenza Vaccine (BIOLOGICAL), Quadrivalent Influenza mRNA Vaccine MRT5407 (BIOLOGICAL), Quadrivalent Influenza High-Dose Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05553301?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05553301's enrollment target sits among peer trials
560 35th of 2000 higher than 1,966 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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