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NCT05083585 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old
A Phase 3 study of Respiratory Syncytial Virus Prevention, sponsored by Janssen Vaccines & Prevention B.V..
- Completed
- Registry status
- Phase 3
- Development phase
- 250
- Enrollment target
- 9
- Study locations
NCT05083585 is a Phase 3 study of Respiratory Syncytial Virus Prevention that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 250 participants. The trial reports 9 study locations across 4 states.
The verdict
NCT05083585, a Phase 3 study of Respiratory Syncytial Virus Prevention, has completed, sponsored by Janssen Vaccines & Prevention B.V..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 250 participants
- Enrollment target
- 9
- Study locations
Study Summary
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses induced by vaccination with one dose of the Phase 3 clinical trial material (CTM) compared with one dose of the Phase 2b CTM.
Conditions Studied
Interventions
- BIOLOGICAL Ad26.RSV.preF-based vaccine
Study Locations (9)
Florida
- Accel Research Sites - Lakeland
- Optimal Research - Melbourne
- Pharmax Research Clinic Inc - Miami
- Research Institute of South Florida Inc - Miami
- Progressive Medical Research - Port Orange
California
- Artemis Institute for Clinical Research - San Diego
- Optimal Research - San Diego
Ohio
- Meridian Clinical Research, LLC - Cincinnati
Texas
- Tekton Research Inc. - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2021-10-08 |
| Est. Completion | 2022-09-22 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05083585
The ClinicalTrials.gov registry entry for NCT05083585 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Vaccines & Prevention B.V., which has 34 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Respiratory Syncytial Virus Prevention appearing as the primary indexed condition, and to 1 intervention - of which Ad26.RSV.preF-based vaccine is the first listed.
NCT05083585 reports 9 study locations spanning 4 distinct geographic areas - top geographies include Florida, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT05083585 about?
NCT05083585 is a clinical study titled "A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old". The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses induced by vaccination with one dose of the Phase 3 clinical trial material (CTM) compared with one dose of the Phase 2b CTM.
What is the current status of trial NCT05083585?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2021-10-08. Estimated completion is 2022-09-22.
What conditions does trial NCT05083585 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus Prevention.
What interventions are being tested in trial NCT05083585?
The interventions under investigation include: Ad26.RSV.preF-based vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05083585?
This trial is sponsored by Janssen Vaccines & Prevention B.V., which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05083585 being conducted?
This trial has 9 study locations across California, Florida, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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