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NCT06237296 · ClinicalTrials.gov registry record · Phase 1
Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older
A Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 558
- Enrollment target
NCT06237296: Completed Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT06237296 is a Phase 1 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 558 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (830% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06237296, a Phase 1 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 558 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and immunogenicity an investigational messenger ribonucleic acid (mRN)A vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV) in older adults. A single intramuscular (IM) injection of 3 to 4 different doses of the RSV/hMPV mRNA vaccine candidate formulated with 2 different lipid nanoparticles (LNP) will be administered to healthy participants aged 18 to 49 years and 60 years and older. Treatment: * RSV/hMPV mRNA / LNP 1 at 3-4 different doses or, * RSV/hMPV mRNA / LNP 2 at 3-4 difference doses or, * RSV mRNA / LNP 1 at 1 dose or, * hMPV mRNA / LNP 1 at 1 dose
Primary Outcome
Number of participants experiencing immediate an immediate unsolicited systemic adverse event
Interventions
- BIOLOGICAL RSV/hMPV mRNA LNP 1
- BIOLOGICAL RSV/hMPV mRNA LNP 2
- BIOLOGICAL RSV mRNA LNP 1
- BIOLOGICAL hMPV mRNA LNP 1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 558 participants |
| Start Date | 2024-01-23 |
| Est. Completion | 2025-02-11 |
| Phase | Phase 1 |
What the finished NCT06237296 record still lists
NCT06237296 is an interventional study that assigns participants to a tested intervention. The registered 558 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 (830% higher).
The record links to 0 conditions, and to 4 interventions - of which RSV/hMPV mRNA LNP 1 is the first listed.
NCT06237296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06237296 about?
NCT06237296 is a clinical study titled "Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older". The purpose of this study is to evaluate the safety and immunogenicity an investigational messenger ribonucleic acid (mRN)A vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV) in older adults. A single i...
What is the current status of trial NCT06237296?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 558 participants. The study started on 2024-01-23. Estimated completion is 2025-02-11.
What interventions are being tested in trial NCT06237296?
The interventions under investigation include: RSV/hMPV mRNA LNP 1 (BIOLOGICAL), RSV/hMPV mRNA LNP 2 (BIOLOGICAL), RSV mRNA LNP 1 (BIOLOGICAL), hMPV mRNA LNP 1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06237296?
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 NCT06237296's enrollment target sits among peer trials
558 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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