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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: Completed Phase 3 study, sponsored by Janssen Vaccines & Prevention B.V..
NCT05091307 is a Phase 3 study that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 861 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
GMTs of HI antibodies were measured using hemagglutination inhibition (HAI) assay against each of four influenza vaccine strains (A/Victoria \[H1N1\], A/Cambodia \[H3N2\], B/Victoria \[B/Victoria\] and B/Phuket \[B/Yamagata\]). This outcome measure was planned to be analyzed for specified arms only. PPII=Per-protocol influenza immunogenicity.
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 |
What the finished NCT05091307 record still lists
NCT05091307 is an interventional study that assigns participants to a tested intervention. The registered 861 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05091307 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05091307's enrollment target sits among peer trials
861 380th of 2000 higher than 1,621 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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