Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults
Public ClinicalTrials.gov record NCT01991587. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent Virus-like-particle (VLP) Influenza Vaccine in Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01991587
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Interventions
- Low dose of quadrivalent VLP vaccine Biological
- Medium dose of quadrivalent VLP vaccine Biological
- High dose of quadrivalent VLP vaccine Biological
- Placebo Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 49 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 7, 2013
- Primary completion
- Jun 29, 2014
- Completion
- Jun 29, 2014
- Last update posted
- Jun 10, 2020
2013 – 2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Miami Research Associates | Miami | Florida | 33143 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01991587, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 10, 2020 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01991587 live on ClinicalTrials.gov.