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NCT03982199 · ClinicalTrials.gov registry record · Phase 2
A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older
A Phase 2 study, sponsored by Janssen Vaccines & Prevention B.V..
- Terminated
- Registry status
- Phase 2
- Development phase
- 5,815
- Enrollment target
NCT03982199: Clinical Trial Phase 2 study, sponsored by Janssen Vaccines & Prevention B.V..
NCT03982199 is a Phase 2 study that was terminated before completion, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 5,815 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (4272% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03982199, a Phase 2 study, was terminated before completion, sponsored by Janssen Vaccines & Prevention B.V..
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5,815 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate the efficacy of active study vaccine in the prevention of reverse transcriptase polymerase chain reaction (RT-PCR) confirmed respiratory syncytial virus (RSV)-mediated lower respiratory tract disease (LRTD), when compared to placebo.
Primary Outcome
Number of participants with first occurrence of RT-PCR-confirmed RSV mediated LRTD according to case definition-1, 2 and 3 were reported. Case definition 1 was defined as having a new onset or worsening in 3 or more symptoms of lower respiratory tract infection (LRTI) ; Case definition 2 was defined as having a new onset or worsening in greater than or equal to (\>=) 2 symptoms of LRTI; and Case definition 3 was defined as having a new onset or worsening in \>=2 OR \>=1 symptoms of LRTI with \>=
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL RSV Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,815 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2023-05-26 |
| Phase | Phase 2 |
Why NCT03982199 stopped before completion
NCT03982199 is an interventional study that assigns participants to a tested intervention. Its 5,815 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (4272% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03982199 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03982199 about?
NCT03982199 is a clinical study titled "A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older". The purpose of this study is to demonstrate the efficacy of active study vaccine in the prevention of reverse transcriptase polymerase chain reaction (RT-PCR) confirmed respiratory syncytial virus (RSV)-mediated lower respiratory tract disease (LRTD), when compared to placebo.
What is the current status of trial NCT03982199?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5,815 participants. The study started on 2019-08-01. Estimated completion is 2023-05-26.
What interventions are being tested in trial NCT03982199?
The interventions under investigation include: Placebo (BIOLOGICAL), RSV Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03982199?
This trial is sponsored by Janssen Vaccines & Prevention B.V., which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03982199's enrollment target sits among peer trials
5,815 1st of 2000 higher than 2,000 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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