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NCT02233816 · ClinicalTrials.gov registry record · Phase 2
Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal Virus-Like-Particle Quadrivalent Influenza Vaccine in Adults
A Phase 2 study, sponsored by Medicago.
- Completed
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
NCT02233816 is a Phase 2 study that has completed, run by Medicago. The registered enrollment target is 300 participants.
The verdict
NCT02233816, a Phase 2 study, has completed, sponsored by Medicago.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
Study Summary
A phase II trial multicenter, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular injection of plant-derived Seasonal VLP Quadrivalent Influenza Vaccine administered to healthy adults 18-49 years of age. A total of three hundred subjects will be randomized in four (4) groups of 75 subjects to receive one injection of either a low, a medium, or a high dose level of the quadrivalent VLP influenza vaccine or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80).
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Low dose of quadrivalent VLP vaccine
- BIOLOGICAL Medium dose of quadrivalent VLP vaccine
- BIOLOGICAL High dose of quadrivalent VLP vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2014-07-28 |
| Est. Completion | 2015-06-22 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02233816
The ClinicalTrials.gov registry entry for NCT02233816 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 300 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 Placebo is the first listed.
NCT02233816 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02233816 about?
NCT02233816 is a clinical study titled "Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal Virus-Like-Particle Quadrivalent Influenza Vaccine in Adults". A phase II trial multicenter, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular injection of plant-derived Seasonal VLP Quadrivalent Influenza Vaccine administered to healthy adults 18-49 years of age...
What is the current status of trial NCT02233816?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2014-07-28. Estimated completion is 2015-06-22.
What interventions are being tested in trial NCT02233816?
The interventions under investigation include: Placebo (BIOLOGICAL), Low dose of quadrivalent VLP vaccine (BIOLOGICAL), Medium dose of quadrivalent VLP vaccine (BIOLOGICAL), High dose of quadrivalent VLP vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02233816?
This trial is sponsored by Medicago, which has 9 total clinical trials registered on ClinicalTrials.gov.
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