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NCT06134648 · ClinicalTrials.gov registry record · Phase 1
Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate
A Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 646
- Enrollment target
NCT06134648: Completed Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT06134648 is a Phase 1 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 646 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (977% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06134648, a Phase 1 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 646 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and immunogenicity of a single intramuscular (IM) injection of different doses of an respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine candidate, in adult participants aged 60 years and older. In addition, the study will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population.
Primary Outcome
Number of participants experiencing immediate an immediate unsolicited systemic adverse event
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL RSV/hMPV vaccine candidate Dose L
- BIOLOGICAL RSV/hMPV vaccine candidate Dose A
- BIOLOGICAL RSV/hMPV vaccine candidate Dose B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 646 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2026-02-27 |
| Phase | Phase 1 |
What the finished NCT06134648 record still lists
NCT06134648 is an interventional study that assigns participants to a tested intervention. The registered 646 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 (977% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT06134648 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06134648 about?
NCT06134648 is a clinical study titled "Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate". The purpose of this study is to assess the safety and immunogenicity of a single intramuscular (IM) injection of different doses of an respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine candidate, in adult participants aged 60 years and older. In addition, the study will eval...
What is the current status of trial NCT06134648?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 646 participants. The study started on 2023-11-01. Estimated completion is 2026-02-27.
What interventions are being tested in trial NCT06134648?
The interventions under investigation include: Placebo (BIOLOGICAL), RSV/hMPV vaccine candidate Dose L (BIOLOGICAL), RSV/hMPV vaccine candidate Dose A (BIOLOGICAL), RSV/hMPV vaccine candidate Dose B (BIOLOGICAL).
Who is sponsoring clinical trial NCT06134648?
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 NCT06134648's enrollment target sits among peer trials
646 22nd of 2000 higher than 1,979 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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