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NCT06118151 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older
A Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 388
- Enrollment target
NCT06118151: Completed Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT06118151 is a Phase 1 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 388 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (547% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06118151, a Phase 1 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 388 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 dose levels of messenger ribonucleic acid (mRNA) vaccine encoding influenza hemagglutinin compared to an active control quadrivalent recombinant influenza vaccine (RIV4) in adults 18 years of age and older. Study details include: Study Duration: approximately 6 months Treatment Duration: 1 injection of mRNA vaccine encoding influenza hemagglutinin encoding influenza hemagglutinin or control. Visit Frequency: Screening visit, Day 01, Day 02, Day 03, Day 09, Day 29, Day 91, Day 181
Primary Outcome
Number of participants with unsolicited systemic immediate adverse events (AEs)
Interventions
- BIOLOGICAL Influenza Hemagglutinin mRNA vaccine
- BIOLOGICAL Quadrivalent Recombinant Influenza Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 388 participants |
| Start Date | 2022-04-11 |
| Est. Completion | 2023-02-17 |
| Phase | Phase 1 |
What the finished NCT06118151 record still lists
NCT06118151 is an interventional study that assigns participants to a tested intervention. The registered 388 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 (547% higher).
The record links to 0 conditions, and to 2 interventions - of which Influenza Hemagglutinin mRNA vaccine is the first listed.
NCT06118151 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06118151 about?
NCT06118151 is a clinical study titled "Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older". The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different dose levels of messenger ribonucleic acid (mRNA) vaccine encoding influenza hemagglutinin compared to an active control quadrivalent recombinant influenza vaccine (RIV4) in ad...
What is the current status of trial NCT06118151?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 388 participants. The study started on 2022-04-11. Estimated completion is 2023-02-17.
What interventions are being tested in trial NCT06118151?
The interventions under investigation include: Influenza Hemagglutinin mRNA vaccine (BIOLOGICAL), Quadrivalent Recombinant Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT06118151?
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 NCT06118151's enrollment target sits among peer trials
388 79th of 2000 higher than 1,922 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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