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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: Completed Phase 3 study of Respiratory Syncytial Virus Prevention, sponsored by Janssen Vaccines & Prevention B.V..
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). The trial reports 9 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV based vaccine were reported.
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 |
What the finished NCT05083585 record still lists
NCT05083585 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).
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 lists 9 locations in 4 states (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.
Learn More About Clinical Trials
Similar trials for Respiratory Syncytial Virus Prevention
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05083585's enrollment target sits among peer trials
250 1249th of 2000 higher than 735 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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