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NCT05101486 · ClinicalTrials.gov registry record · Phase 3
A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
A Phase 3 study of Respiratory Syncytial Virus Prevention, sponsored by Janssen Vaccines & Prevention B.V..
- Completed
- Registry status
- Phase 3
- Development phase
- 755
- Enrollment target
- 13
- Study locations
NCT05101486: Completed Phase 3 study of Respiratory Syncytial Virus Prevention, sponsored by Janssen Vaccines & Prevention B.V..
NCT05101486 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 755 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05101486, 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
- 755 participants
- Enrollment target
- 13
- Study locations
Study Summary
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.
Primary Outcome
GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV vaccine were reported.
Conditions Studied
Interventions
- BIOLOGICAL Ad26.RSV.PreF-based Vaccine
Study Locations (13)
Florida
- Accel Research Sites - DeLand
- Pharmax Research Clinic Inc - Miami
- Suncoast Research Group - Miami
- Suncoast Research Associates, LLC - Miami
Alabama
- North Alabama Research Center, LLC - Athens
- Achieve Clinical Research, LLC - Vestavia Hills
Arizona
- Hope Research Institute - Phoenix
Connecticut
- Clinical Research Consulting - Milford
Georgia
- Atlanta Center for Medical Research - Atlanta
Maryland
- Centennial Medical Group - Elkridge
Nebraska
- Be Well Clinical Studies - Lincoln
North Carolina
- American Health Network, LLC - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 755 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2022-09-20 |
| Phase | Phase 3 |
What the finished NCT05101486 record still lists
NCT05101486 is an interventional study that assigns participants to a tested intervention. The registered 755 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
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.
NCT05101486 lists 13 locations in 9 states (Florida, Alabama, Arizona).
Frequently Asked Questions
What is clinical trial NCT05101486 about?
NCT05101486 is a clinical study titled "A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years". The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.
What is the current status of trial NCT05101486?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 755 participants. The study started on 2021-11-01. Estimated completion is 2022-09-20.
What conditions does trial NCT05101486 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus Prevention.
What interventions are being tested in trial NCT05101486?
The interventions under investigation include: Ad26.RSV.PreF-based Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05101486?
This trial is sponsored by Janssen Vaccines & Prevention B.V., which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05101486 being conducted?
This trial has 13 study locations across Alabama, Arizona, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT05101486's enrollment target sits among peer trials
755 459th of 2000 higher than 1,541 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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