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NCT05091307 · ClinicalTrials.gov registry record · Phase 3
A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults
A Phase 3 study, sponsored by Janssen Vaccines & Prevention B.V..
- Completed
- Registry status
- Phase 3
- Development phase
- 861
- Enrollment target
NCT05091307 is a Phase 3 study that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 861 participants.
The verdict
NCT05091307, a Phase 3 study, has completed, sponsored by Janssen Vaccines & Prevention B.V..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 861 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate the non-inferiority (NI) of the humoral immune response of the 4 influenza vaccine strains after concomitant administration of the Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of a seasonal quadrivalent standard-dose influenza vaccine administered alone; and to demonstrate the NI of the binding antibody response after concomitant administration of Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of Ad26.COV2.S vaccine administered alone.
Interventions
- OTHER Placebo
- BIOLOGICAL Influenza Vaccine
- BIOLOGICAL Ad26.COV2.S
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 861 participants |
| Start Date | 2021-11-02 |
| Est. Completion | 2022-11-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05091307
The ClinicalTrials.gov registry entry for NCT05091307 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 861 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Vaccines & Prevention B.V., which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05091307 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05091307 about?
NCT05091307 is a clinical study titled "A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults". The purpose of this study is to demonstrate the non-inferiority (NI) of the humoral immune response of the 4 influenza vaccine strains after concomitant administration of the Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of a seasonal quadr...
What is the current status of trial NCT05091307?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 861 participants. The study started on 2021-11-02. Estimated completion is 2022-11-15.
What interventions are being tested in trial NCT05091307?
The interventions under investigation include: Placebo (OTHER), Influenza Vaccine (BIOLOGICAL), Ad26.COV2.S (BIOLOGICAL).
Who is sponsoring clinical trial NCT05091307?
This trial is sponsored by Janssen Vaccines & Prevention B.V., which has 34 total clinical trials registered on ClinicalTrials.gov.
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