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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: Completed Phase 2 study, sponsored by Medicago.
NCT02233816 is a Phase 2 study that has completed, run by Medicago. The registered enrollment target is 300 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Immunogenicity will be assessed by Geometric mean titers (GMTs) of hemagglutination inhibition (HI antibody on Days 0 and 21) antibodies against the vaccine strains and assessed by measuring geometric mean fold rise, seroconversion rate and seroprotection rate. Follow up serology samples for GMTs will be collected at day 201.
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 |
What the finished NCT02233816 record still lists
NCT02233816 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02233816 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02233816's enrollment target sits among peer trials
300 167th of 2000 higher than 1,813 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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