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NCT05639894 · ClinicalTrials.gov registry record · Phase 1
Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older
A Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 865
- Enrollment target
NCT05639894 is a Phase 1 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 865 participants.
The verdict
NCT05639894, a Phase 1 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 865 participants
- Enrollment target
Study Summary
Brief Summary of Stage 1: The purpose Stage 1 (Phase I/IIa) is to assess the safety and immunogenicity of a single intramuscular (IM) injection of 3 dose-levels of an Respiratory Syncytial Virus (RSV) vaccine candidate formulated with 2 different lipid nanoparticles (LNPs) in healthy adult participants aged between 18 to 50 years, and 60 years and older. The primary objectives of this stage are to assess the safety and immunogenicity profiles across the dose-level groups (low, medium, and high doses) with 2 LNPs. This stage will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population. Brief Summary of Stage 2: The study also also incorporates a Stage 2 (Phase IIa, dose-ranging design) that includes adults aged 60 years and older to assess the safety and immunogenicity of different doses of RSV vaccine encapsulated in one of the LNPs. In the Phase IIa dose-ranging stage, eligible participants will be randomly assigned in a 1:1:1 ratio to receive a single IM administration of RSV vaccine candidate doses, or placebo. Multiple safety analyses will be performed, minimally at D07 and D28. Additional analyses may be performed as data are available.
Interventions
- OTHER Placebo
- BIOLOGICAL RSV vaccine candiate formulation 1
- BIOLOGICAL RSV vaccine candidate formulation 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 865 participants |
| Start Date | 2022-11-17 |
| Est. Completion | 2025-05-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05639894
The ClinicalTrials.gov registry entry for NCT05639894 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 865 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05639894 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05639894 about?
NCT05639894 is a clinical study titled "Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older". Brief Summary of Stage 1: The purpose Stage 1 (Phase I/IIa) is to assess the safety and immunogenicity of a single intramuscular (IM) injection of 3 dose-levels of an Respiratory Syncytial Virus (RSV) vaccine candidate formulated with 2 different lipid nanoparticles (LNPs) in healthy adult particip...
What is the current status of trial NCT05639894?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 865 participants. The study started on 2022-11-17. Estimated completion is 2025-05-02.
What interventions are being tested in trial NCT05639894?
The interventions under investigation include: Placebo (OTHER), RSV vaccine candiate formulation 1 (BIOLOGICAL), RSV vaccine candidate formulation 2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05639894?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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