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NCT05070546 · ClinicalTrials.gov registry record · Phase 3
A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection
A Phase 3 study, sponsored by Janssen Vaccines & Prevention B.V..
- Completed
- Registry status
- Phase 3
- Development phase
- 1,124
- Enrollment target
NCT05070546: Completed Phase 3 study, sponsored by Janssen Vaccines & Prevention B.V..
NCT05070546 is a Phase 3 study that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 1,124 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05070546, a Phase 3 study, has completed, sponsored by Janssen Vaccines & Prevention B.V..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,124 participants
- Enrollment target
Study Summary
The purpose of the study is to investigate the safety and immunogenicity of the Ad26.RSV.preF based vaccine in adults 18 to 59 years of age who are healthy or at risk for severe Respiratory Syncytial Virus (RSV) disease, compared to adults 65 years and above.
Primary Outcome
Number of participants with solicited local AEs at 7 days post-vaccination in Cohorts 1 and 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were predefined local events (at the injection site: erythema, pain/tenderness and swelling) that were by definition considered as related to the study vaccine and collecte
Interventions
- OTHER Placebo
- BIOLOGICAL Ad26.RSV.preF-based Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,124 participants |
| Start Date | 2021-09-29 |
| Est. Completion | 2022-08-12 |
| Phase | Phase 3 |
What the finished NCT05070546 record still lists
NCT05070546 is an interventional study that assigns participants to a tested intervention. Its 1,124 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05070546 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05070546 about?
NCT05070546 is a clinical study titled "A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection". The purpose of the study is to investigate the safety and immunogenicity of the Ad26.RSV.preF based vaccine in adults 18 to 59 years of age who are healthy or at risk for severe Respiratory Syncytial Virus (RSV) disease, compared to adults 65 years and above.
What is the current status of trial NCT05070546?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,124 participants. The study started on 2021-09-29. Estimated completion is 2022-08-12.
What interventions are being tested in trial NCT05070546?
The interventions under investigation include: Placebo (OTHER), Ad26.RSV.preF-based Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05070546?
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 NCT05070546's enrollment target sits among peer trials
1,124 248th of 2000 higher than 1,753 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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