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NCT01991587 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults
A Phase 1 study, sponsored by Medicago.
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
NCT01991587: Completed Phase 1 study, sponsored by Medicago.
NCT01991587 is a Phase 1 study that has completed, run by Medicago. The registered enrollment target is 120 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01991587, a Phase 1 study, has completed, sponsored by Medicago.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
Study Summary
A phase I/II trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a single intramuscular injection of plant-based Seasonal Quadrivalent VLP Influenza Vaccine administered to healthy adults 18-49 years of age. A total of one hundred and twenty (120) subjects will be randomized in four (4) groups of 30 subjects to receive one injection of either a low, a medium, or a high dose level of VLP 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 | 120 participants |
| Start Date | 2013-10-08 |
| Est. Completion | 2014-06-30 |
| Phase | Phase 1 |
What the finished NCT01991587 record still lists
NCT01991587 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01991587 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01991587 about?
NCT01991587 is a clinical study titled "Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults". A phase I/II trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a single intramuscular injection of plant-based Seasonal Quadrivalent VLP Influenza Vaccine administered to healthy adults 1...
What is the current status of trial NCT01991587?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2013-10-08. Estimated completion is 2014-06-30.
What interventions are being tested in trial NCT01991587?
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 NCT01991587?
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 NCT01991587's enrollment target sits among peer trials
120 479th of 2000 higher than 1,503 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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