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NCT06361875 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above
A Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 910
- Enrollment target
NCT06361875: Completed Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT06361875 is a Phase 1 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 910 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1417% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06361875, a Phase 1 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 910 participants
- Enrollment target
Study Summary
The purpose of this study is 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.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination. Systemic AEs are all AEs that were not injection or administration site reactions. Immediate events are recorded to cap
Interventions
- BIOLOGICAL Quadrivalent Influenza Standard Dose Vaccine
- BIOLOGICAL Quadrivalent Influenza High-Dose Vaccine
- BIOLOGICAL Quadrivalent Influenza mRNA Vaccine MRT5421
- BIOLOGICAL Quadrivalent Influenza mRNA Vaccine MRT5424
- BIOLOGICAL Quadrivalent Influenza mRNA Vaccine MRT5429
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 910 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2025-06-09 |
| Phase | Phase 1 |
What the finished NCT06361875 record still lists
NCT06361875 is an interventional study that assigns participants to a tested intervention. The registered 910 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 (1417% higher).
The record links to 0 conditions, and to 5 interventions - of which Quadrivalent Influenza Standard Dose Vaccine is the first listed.
NCT06361875 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06361875 about?
NCT06361875 is a clinical study titled "A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above". The purpose of this study is 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), ...
What is the current status of trial NCT06361875?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 910 participants. The study started on 2024-04-01. Estimated completion is 2025-06-09.
What interventions are being tested in trial NCT06361875?
The interventions under investigation include: Quadrivalent Influenza Standard Dose Vaccine (BIOLOGICAL), Quadrivalent Influenza High-Dose Vaccine (BIOLOGICAL), Quadrivalent Influenza mRNA Vaccine MRT5421 (BIOLOGICAL), Quadrivalent Influenza mRNA Vaccine MRT5424 (BIOLOGICAL), Quadrivalent Influenza mRNA Vaccine MRT5429 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06361875?
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 NCT06361875's enrollment target sits among peer trials
910 11th of 2000 higher than 1,990 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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