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NCT02831751 · ClinicalTrials.gov registry record · Phase 2
Immunogenicity, Safety, and Tolerability of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Elderly Adults
A Phase 2 study, sponsored by Medicago.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,001
- Enrollment target
NCT02831751 is a Phase 2 study that has completed, run by Medicago. The registered enrollment target is 1,001 participants.
The verdict
NCT02831751, a Phase 2 study, has completed, sponsored by Medicago.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,001 participants
- Enrollment target
Study Summary
This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The study is being conducted to evaluate that the immunogenicity profile of the Quadrivalent VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure criteria and to evaluate if the immunogenicity and the safety profile of the Quadrivalent VLP Vaccine is acceptable and comparable to that of the FluLaval® Tetra and Fluzone® High-Dose (HD). The study will also help to define the optimal dose in this population, establish potential competitive advantages, and support the design of future studies.
Interventions
- BIOLOGICAL 30 µg/strain of Quadrivalent VLP Vaccine
- BIOLOGICAL 60 µg/strain of Quadrivalent VLP Vaccine
- BIOLOGICAL FluLaval® Tetra (15 µg/strain)
- BIOLOGICAL Fluzone® High-Dose (60 µg/strain)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,001 participants |
| Start Date | 2016-04 |
| Est. Completion | 2017-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02831751
The ClinicalTrials.gov registry entry for NCT02831751 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,001 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medicago, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which 30 µg/strain of Quadrivalent VLP Vaccine is the first listed.
NCT02831751 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02831751 about?
NCT02831751 is a clinical study titled "Immunogenicity, Safety, and Tolerability of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Elderly Adults". This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The study is being conducted to evaluate that the immunogenicity profile of the Quadrivalent VLP Vaccine meets the US Center for Bi...
What is the current status of trial NCT02831751?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,001 participants. The study started on 2016-04. Estimated completion is 2017-01.
What interventions are being tested in trial NCT02831751?
The interventions under investigation include: 30 µg/strain of Quadrivalent VLP Vaccine (BIOLOGICAL), 60 µg/strain of Quadrivalent VLP Vaccine (BIOLOGICAL), FluLaval® Tetra (15 µg/strain) (BIOLOGICAL), Fluzone® High-Dose (60 µg/strain) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02831751?
This trial is sponsored by Medicago, which has 9 total clinical trials registered on ClinicalTrials.gov.
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