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NCT04908683 · ClinicalTrials.gov registry record · Phase 3
A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older
A Phase 3 study, sponsored by Janssen Vaccines & Prevention B.V..
- Completed
- Registry status
- Phase 3
- Development phase
- 25,236
- Enrollment target
NCT04908683: Completed Phase 3 study, sponsored by Janssen Vaccines & Prevention B.V..
NCT04908683 is a Phase 3 study that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 25,236 participants, above the 770-participant average among 15,282 other Phase 3 trials with a reported enrollment target (3177% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04908683, a Phase 3 study, has completed, sponsored by Janssen Vaccines & Prevention B.V..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 25,236 participants
- Enrollment target
Study Summary
The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.
Primary Outcome
Number of participants with first occurrence of RT-PCR-confirmed RSV mediated LRTD according to protocol defined criteria were reported. A participant was considered to have RT-PCR-confirmed RSV-mediated LRTD if the following criteria were met: new onset or worsening from baseline of 3 or more of the symptoms as captured on the respiratory infection intensity and impact questionnaire (RiiQ, version 2) at the same assessment time point: cough, short of breath, coughing up phlegm (sputum), and whe
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25,236 participants |
| Start Date | 2021-07-21 |
| Est. Completion | 2023-07-21 |
| Phase | Phase 3 |
What the finished NCT04908683 record still lists
NCT04908683 is an interventional study that assigns participants to a tested intervention. Its 25,236 participants enrollment target places it among the larger protocols in the corpus, above the 770-participant average among 15,282 other Phase 3 trials with a reported enrollment target (3177% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04908683 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04908683 about?
NCT04908683 is a clinical study titled "A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older". The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRT...
What is the current status of trial NCT04908683?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 25,236 participants. The study started on 2021-07-21. Estimated completion is 2023-07-21.
What interventions are being tested in trial NCT04908683?
The interventions under investigation include: Placebo (BIOLOGICAL), Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF (BIOLOGICAL).
Who is sponsoring clinical trial NCT04908683?
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 NCT04908683's enrollment target sits among peer trials
25,236 8th of 2000 higher than 1,993 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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