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NCT05650554 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 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
- 682
- Enrollment target
NCT05650554: Completed Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT05650554 is a Phase 1 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 682 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1037% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05650554, a Phase 1 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 682 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 3 dose levels of Quadrivalent Influenza messenger ribonucleic acid (mRNA) Vaccine MRT5413 compared to an active control (QIVstandard-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 High-Dose Vaccine
- BIOLOGICAL Quadrivalent Influenza mRNA Vaccine MRT5413
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 682 participants |
| Start Date | 2022-12-12 |
| Est. Completion | 2024-04-02 |
| Phase | Phase 1 |
What the finished NCT05650554 record still lists
NCT05650554 is an interventional study that assigns participants to a tested intervention. The registered 682 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 (1037% higher).
The record links to 0 conditions, and to 4 interventions - of which Quadrivalent Influenza Standard Dose Vaccine is the first listed.
NCT05650554 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05650554 about?
NCT05650554 is a clinical study titled "Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 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 3 dose levels of Quadrivalent Influenza messenger ribonucleic acid (mRNA) Vaccine MRT5413 compared to an active control (QIVstandard-dose (SD), QIV high-dose (HD) \[adults ≥ 65 ye...
What is the current status of trial NCT05650554?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 682 participants. The study started on 2022-12-12. Estimated completion is 2024-04-02.
What interventions are being tested in trial NCT05650554?
The interventions under investigation include: Quadrivalent Influenza Standard Dose Vaccine (BIOLOGICAL), Quadrivalent Recombinant Influenza Vaccine (BIOLOGICAL), Quadrivalent Influenza High-Dose Vaccine (BIOLOGICAL), Quadrivalent Influenza mRNA Vaccine MRT5413 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05650554?
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 NCT05650554's enrollment target sits among peer trials
682 21st of 2000 higher than 1,980 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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