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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 is a Phase 1 study that has completed, run by Medicago. The registered enrollment target is 120 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01991587
The ClinicalTrials.gov registry entry for NCT01991587 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 120 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.
NCT01991587 reports 0 study locations.
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.
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