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NCT05071313 · ClinicalTrials.gov registry record · Phase 3
A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older
A Phase 3 study, sponsored by Janssen Vaccines & Prevention B.V..
- Completed
- Registry status
- Phase 3
- Development phase
- 777
- Enrollment target
NCT05071313: Completed Phase 3 study, sponsored by Janssen Vaccines & Prevention B.V..
NCT05071313 is a Phase 3 study that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 777 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05071313, a Phase 3 study, has completed, sponsored by Janssen Vaccines & Prevention B.V..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 777 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately.
Primary Outcome
Hemagglutination is a phenomenon by which the hemagglutinin protein of influenza viruses can bind to sialic acid receptors on the red blood cell membrane, thereby forming clumps and is the basis for the HI assay. GMTs of HI antibodies against each of the four influenza vaccine strains as measured by HI assay at 28 days after the administration of a quadrivalent high-dose seasonal influenza vaccine (fluzone) were reported. The analysis was performed on 2 influenza A strains \[A/Victoria and A/Tas
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Ad26.RSV.preF-based vaccine
- BIOLOGICAL Quadrivalent High-dose Influenza Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 777 participants |
| Start Date | 2021-10-04 |
| Est. Completion | 2022-10-11 |
| Phase | Phase 3 |
What the finished NCT05071313 record still lists
NCT05071313 is an interventional study that assigns participants to a tested intervention. The registered 777 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 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05071313 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05071313 about?
NCT05071313 is a clinical study titled "A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older". The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately.
What is the current status of trial NCT05071313?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 777 participants. The study started on 2021-10-04. Estimated completion is 2022-10-11.
What interventions are being tested in trial NCT05071313?
The interventions under investigation include: Placebo (BIOLOGICAL), Ad26.RSV.preF-based vaccine (BIOLOGICAL), Quadrivalent High-dose Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05071313?
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 NCT05071313's enrollment target sits among peer trials
777 438th of 2000 higher than 1,562 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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