<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02233816</url>
  </required_header>
  <id_info>
    <org_study_id>CP-Q13VLP-007</org_study_id>
    <nct_id>NCT02233816</nct_id>
  </id_info>
  <brief_title>Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal Virus-Like-Particle Quadrivalent Influenza Vaccine in Adults</brief_title>
  <official_title>Immunogenicity, Safety, and Tolerability of a Plant-Derived Seasonal Virus-Like-Particle Quadrivalent Influenza Vaccine in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medicago</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A phase II trial multicenter, observer-blind, randomized, dose-ranging, placebo-controlled&#xD;
      study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular&#xD;
      injection of plant-derived Seasonal VLP Quadrivalent Influenza Vaccine administered to&#xD;
      healthy adults 18-49 years of age.&#xD;
&#xD;
      A total of three hundred subjects will be randomized in four (4) groups of 75 subjects to&#xD;
      receive one injection of either a low, a medium, or a high dose level of the quadrivalent VLP&#xD;
      influenza vaccine or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM&#xD;
      sodium chloride (NaCl) + 0.01% Tween 80).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a dose escalation, cohort staggering (slow enrollment) for the 3 dose&#xD;
      levels (low, medium or high dose level) with a placebo-controlled group:&#xD;
&#xD;
        -  Cohort 1: A first cohort of one hundred nineteen subjects (119) will be randomized; of&#xD;
           these, seventy five (75) will be dosed with the lowest dose of the quadrivalent VLP&#xD;
           vaccine, nineteen (19) will be dosed with the medium dose of the quadrivalent VLP&#xD;
           vaccine, and twenty five (25) will receive a placebo. The 7-day safety data after the&#xD;
           immunization will be collected and reviewed by the Data and Safety Monitoring Board&#xD;
           (DSMB) consisting of the Principal Investigator (PI), the Sponsor's Medical Officer and&#xD;
           three external medical experts as voting members, prior to permitting immunization with&#xD;
           the cohort 2.&#xD;
&#xD;
        -  Cohort 2: A second cohort of one hundred subjects (100) subjects will be randomized; of&#xD;
           these, fifty six (56) will be dosed with the medium dose of the quadrivalent VLP&#xD;
           vaccine, nineteen (19) be dosed with the high dose of the quadrivalent VLP vaccine, and&#xD;
           twenty five (25) will receive a placebo. The 7-day safety data after the immunization&#xD;
           will be collected and reviewed by the DSMB, prior to permitting immunization with the&#xD;
           highest dose.&#xD;
&#xD;
        -  Cohort 3: A third cohort of eighty one subjects (81) subjects will be randomized; of&#xD;
           these fifty six (56) dosed with the high dose of the quadrivalent VLP vaccine and twenty&#xD;
           five (25) will receive a placebo.&#xD;
&#xD;
      Three (3) and 21 days after immunization, key safety (Day 3) and immunogenicity (Day 21) data&#xD;
      will be collected and analyzed. All subjects will be followed for safety until Day 201&#xD;
      (6-month follow up), regardless the phase of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2014</start_date>
  <completion_date type="Actual">June 22, 2015</completion_date>
  <primary_completion_date type="Actual">June 22, 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Immunogenicity (against vaccine strains)</measure>
    <time_frame>21 days after injection</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety</measure>
    <time_frame>21 days after injection</time_frame>
    <description>Safety and tolerability will be assessed by the rate, severity and relationship to vaccination of solicited and unsolicited adverse events post-vaccination. A 6-month follow up period will be performed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity (against vaccine strains and heterologous strains)</measure>
    <time_frame>21 days after injection</time_frame>
    <description>Immunogenicity will be assessed by Geometric mean titers (GMTs) of microneutralization (MN antibody on Days 0 and 21) antibodies against the vaccine strains and assessed by measuring Geometric mean fold rise and seroconversion rate. Cross-reactivity of antibodies induced by a single dose of the quadrivalent VLP vaccine will also be assessed and measured by HI and microneutralization (MN) antibody titers for heterologous influenza strains. This will be assessed using the measures of Geometric mean fold rise, seroconversion rate and seroprotection rate (for HI only).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Virus Diseases</condition>
  <condition>RNA Virus Infections</condition>
  <condition>Respiratory Tract Diseases</condition>
  <condition>Respiratory Tract Infections</condition>
  <arm_group>
    <arm_group_label>Low dose of quadrivalent VLP vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single low dose of quadrivalent VLP vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium dose of quadrivalent VLP vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single medium dose of quadrivalent VLP vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose of quadrivalent VLP vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single high dose of quadrivalent VLP vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A single dose of Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Low dose of quadrivalent VLP vaccine</intervention_name>
    <description>A single low dose of quadrivalent VLP vaccine</description>
    <arm_group_label>Low dose of quadrivalent VLP vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Medium dose of quadrivalent VLP vaccine</intervention_name>
    <description>A single medium dose of quadrivalent VLP vaccine</description>
    <arm_group_label>Medium dose of quadrivalent VLP vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>High dose of quadrivalent VLP vaccine</intervention_name>
    <description>A single high dose of quadrivalent VLP vaccine</description>
    <arm_group_label>High dose of quadrivalent VLP vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>A single dose of placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female adults, 18 to 49 years of age, inclusive.&#xD;
&#xD;
          2. Body mass index (BMI) of ≥18 and ≤32.&#xD;
&#xD;
          3. Give his/her consent to participate in this study (by signing the informed consent&#xD;
             form). In the opinion of the Investigator, competence and willingness to provide&#xD;
             written, informed consent for participation after reading the informed consent form.&#xD;
             The subject must have adequate opportunity to discuss the study with an Investigator&#xD;
             or qualified designee.&#xD;
&#xD;
          4. Healthy as judged by the Investigator or designee and determined by complete general&#xD;
             physical examination, vital signs, clinical laboratory tests, and medical history&#xD;
             conducted no more than 30 days prior to study vaccine administration. Subjects with a&#xD;
             pre-existing chronic disease will be allowed to participate if the disease is stable&#xD;
             and, according to the Investigator's judgment, the condition is unlikely to confound&#xD;
             the results of the study or pose additional risk to the subject by participating in&#xD;
             the study. Stable disease is generally defined as no new onset of exacerbation of&#xD;
             pre-existing chronic disease 6 months prior to immunization. Based on the&#xD;
             Investigator's judgment, a subject with more recent stabilization of a disease could&#xD;
             also be eligible.&#xD;
&#xD;
          5. Comprehension of the study requirements, expressed availability for the required study&#xD;
             period, ability to attend scheduled visits, accessible by phone on a consistent basis.&#xD;
&#xD;
          6. If female, have a negative serum pregnancy test result at screening and negative urine&#xD;
             pregnancy test on Day 0 prior to immunization.&#xD;
&#xD;
          7. Female of childbearing potential must use an effective method of contraception for 1&#xD;
             month prior to immunization and agrees to continue employing adequate birth control&#xD;
             measures for at least 60 days post-immunization. Moreover, she must have no plan to&#xD;
             become pregnant for at least 2 months post-immunization. Abstinent subjects should be&#xD;
             asked what method(s) they would use, should their circumstances change, and subjects&#xD;
             without a well-defined plan should be excluded.&#xD;
&#xD;
             The following relationship or methods of contraception are considered to be effective:&#xD;
&#xD;
               -  Hormonal contraceptives (e.g., injectable, topical [patch], estrogenic vaginal&#xD;
                  ring, etc.);&#xD;
&#xD;
               -  Intra-uterine device (IUD) with or without hormonal release;&#xD;
&#xD;
               -  Male partner using a condom plus spermicide or sterilized partner (at least 1&#xD;
                  year prior to immunization);&#xD;
&#xD;
               -  Credible history of abstinence (self-reported);&#xD;
&#xD;
               -  Heterosexual abstinence at least 60 days post-immunization;&#xD;
&#xD;
               -  Female partner.&#xD;
&#xD;
          8. Non-childbearing females defines as:&#xD;
&#xD;
               -  Surgically-sterile (defined as bilateral tubal ligation or hysterectomy performed&#xD;
                  more than 1 month prior to immunization);&#xD;
&#xD;
               -  Post-menopausal (absence of menses for 24 consecutive months and age consistent&#xD;
                  with natural cessation of ovulation).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. According to Investigator's opinion, presence of significant acute or chronic,&#xD;
             uncontrolled medical or neuropsychiatric illness. &quot;Uncontrolled&quot; is defined as:&#xD;
&#xD;
               -  Requiring a new medical or surgical treatment within one month prior to study&#xD;
                  vaccine administration;&#xD;
&#xD;
               -  Requiring a change in medication dosage in one month prior to study vaccine&#xD;
                  administration due to uncontrolled symptoms or drug toxicity (elective dosage&#xD;
                  adjustments in stable subjects are acceptable).&#xD;
&#xD;
          2. Any medical or neuropsychiatric condition or any history of excessive alcohol use or&#xD;
             drug abuse which, in the Investigator's opinion, would render the subject unable to&#xD;
             provide informed consent or unable to provide valid safety observations and reporting.&#xD;
&#xD;
          3. Any autoimmune disease or any confirmed or suspected immunosuppressive condition or&#xD;
             immunodeficiency including history of human immunodeficiency virus (HIV) infection,&#xD;
             Hepatitis B or C, or the presence of lymphoproliferative disease.&#xD;
&#xD;
          4. Administration of any vaccine (including any other influenza vaccine) within 30 days&#xD;
             prior to study enrolment or planned administration within the period from the&#xD;
             vaccination up to blood sampling at Day 21 or within 30 days prior to blood sampling&#xD;
             at Day 201. Immunization on an emergency basis will be evaluated case-by-case by the&#xD;
             Investigator.&#xD;
&#xD;
          5. Administration of any adjuvanted or investigational influenza vaccine within 1 year&#xD;
             prior to the study enrolment or planned administration prior to the end of this study&#xD;
             (Day 201). Administration of any 'standard', not adjuvanted influenza vaccine (e.g.:&#xD;
             live attenuated Trivalent Inactivated Vaccine (TIV) or Quadrivalent Inactivated&#xD;
             Vaccine (QIV) vaccine IN or split TIV or QIV vaccine by either intra-dermal or&#xD;
             intramuscular route) prior to the 30 day exclusion period mentioned above would be&#xD;
             acceptable.&#xD;
&#xD;
          6. Use of any investigational or non-registered product within 30 days prior to study&#xD;
             enrolment or planned use during the study period. Subjects may not participate in any&#xD;
             other investigational or marketed drug study while participating in this study&#xD;
             (approximately 8 months).&#xD;
&#xD;
          7. Treatment with systemic glucocorticoids at a dose exceeding 10 mg of prednisone per&#xD;
             day, or equivalent for more than 7 consecutive days or for 10 or more days in total,&#xD;
             within one month of study vaccine administration, any other cytotoxic or&#xD;
             immunosuppressant drug, or any immunoglobulin preparation within 3 months of&#xD;
             vaccination. Low doses of nasal or inhaled glucocorticoids are allowed.&#xD;
&#xD;
          8. Any significant disorder of coagulation or treatment with warfarin derivatives or&#xD;
             heparin. Persons receiving prophylactic anti-platelet medications (e.g., low-dose&#xD;
             aspirin [no more than 325 mg/day]), and without a clinically apparent bleeding&#xD;
             tendency are eligible. Subjects treated with new generation drugs that will not&#xD;
             increase risk of intramuscular bleeding (such as clopidogrel) are also eligible.&#xD;
&#xD;
          9. History of allergy to any of the constituents of the VLP quadrivalent study vaccine,&#xD;
             or to the phosphate buffered saline (PBS; used as placebo), or tobacco allergy.&#xD;
&#xD;
         10. History of anaphylactic allergic reactions to any food, medication or bee sting.&#xD;
&#xD;
         11. Any history of asthma (eg: status asthmatic, hospitalization for asthma control) or&#xD;
             recurrent asthma episodes requiring medical attention in the last 3 years (≥ 1&#xD;
             episode/year).&#xD;
&#xD;
         12. Continuous use of anti-histamines in the last 4 weeks prior to immunization or use of&#xD;
             anti-histamines 48 hours prior to study immunization.&#xD;
&#xD;
         13. Have a rash, dermatological condition, tattoos, muscle mass or any other abnormalities&#xD;
             at injection site which may interfere with injection site reaction rating.&#xD;
&#xD;
         14. Have received a blood transfusion within 90 days prior to study vaccination.&#xD;
&#xD;
         15. If female, have a positive or doubtful pregnancy test result prior to immunization or&#xD;
             lactating females.&#xD;
&#xD;
         16. Vital sign abnormalities (systolic blood pressure and/or diastolic blood pressure,&#xD;
             heart rate and respiratory rate. Although a vital signs measurement is out of the&#xD;
             acceptable ranges, a subject may be included in the study based on Investigator's&#xD;
             judgment. Presence of any febrile illness (including oral temperature (OT) ≥38.0˚C&#xD;
             within 24 hours prior to immunization). Such subjects may be re-evaluated for&#xD;
             enrolment after resolution of illness.&#xD;
&#xD;
         17. Cancer or treatment for cancer within 3 years of study vaccine administration. Persons&#xD;
             with a history of cancer who are disease-free without treatment for 3 years or more&#xD;
             are eligible. Persons with treated and uncomplicated basal cell carcinoma of the skin&#xD;
             are eligible. Person with non-treated, non-disseminated local prostate cancer are&#xD;
             eligible.&#xD;
&#xD;
         18. Identified as an Investigator or employee of the Investigator or clinical site with&#xD;
             direct involvement in the proposed study, or identified as an immediate family member&#xD;
             (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with&#xD;
             direct involvement in the proposed study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Sheldon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Miami Research Associate</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David J Seiden, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Broward Research Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Broward Research Group</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Research Associates</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Pillet S, Couillard J, Trepanier S, Poulin JF, Yassine-Diab B, Guy B, Ward BJ, Landry N. Immunogenicity and safety of a quadrivalent plant-derived virus like particle influenza vaccine candidate-Two randomized Phase II clinical trials in 18 to 49 and &gt;/=50 years old adults. PLoS One. 2019 Jun 5;14(6):e0216533. doi: 10.1371/journal.pone.0216533. eCollection 2019.</citation>
    <PMID>31166987</PMID>
  </results_reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>November 11, 2019</last_update_submitted>
  <last_update_submitted_qc>November 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>Human</keyword>
  <keyword>RNA Virus Infections</keyword>
  <keyword>Immunologic</keyword>
  <keyword>Immunogenic Factors</keyword>
  <keyword>Physiological Effects of Drugs</keyword>
  <keyword>Virus diseases</keyword>
  <keyword>Orthomyxoviridae Infections</keyword>
  <keyword>Infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>RNA Virus Infections</mesh_term>
    <mesh_term>Respiratory Tract Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02233816
org study id: CP-Q13VLP-007
nct id: NCT02233816
lead sponsor: 
has dmc: Yes
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).
This study will be a dose escalation, cohort staggering (slow enrollment) for the 3 dose
      levels (low, medium or high dose level) with a placebo-controlled group:

        -  Cohort 1: A first cohort of one hundred nineteen subjects (119) will be randomized; of
           these, seventy five (75) will be dosed with the lowest dose of the quadrivalent VLP
           vaccine, nineteen (19) will be dosed with the medium dose of the quadrivalent VLP
           vaccine, and twenty five (25) will receive a placebo. The 7-day safety data after the
           immunization will be collected and reviewed by the Data and Safety Monitoring Board
           (DSMB) consisting of the Principal Investigator (PI), the Sponsor's Medical Officer and
           three external medical experts as voting members, prior to permitting immunization with
           the cohort 2.

        -  Cohort 2: A second cohort of one hundred subjects (100) subjects will be randomized; of
           these, fifty six (56) will be dosed with the medium dose of the quadrivalent VLP
           vaccine, nineteen (19) be dosed with the high dose of the quadrivalent VLP vaccine, and
           twenty five (25) will receive a placebo. The 7-day safety data after the immunization
           will be collected and reviewed by the DSMB, prior to permitting immunization with the
           highest dose.

        -  Cohort 3: A third cohort of eighty one subjects (81) subjects will be randomized; of
           these fifty six (56) dosed with the high dose of the quadrivalent VLP vaccine and twenty
           five (25) will receive a placebo.

      Three (3) and 21 days after immunization, key safety (Day 3) and immunogenicity (Day 21) data
      will be collected and analyzed. All subjects will be followed for safety until Day 201
      (6-month follow up), regardless the phase of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Immunogenicity (against vaccine strains)
time frame: 21 days after injection
description: 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.
measure: Safety
time frame: 21 days after injection
description: Safety and tolerability will be assessed by the rate, severity and relationship to vaccination of solicited and unsolicited adverse events post-vaccination. A 6-month follow up period will be performed.
measure: Immunogenicity (against vaccine strains and heterologous strains)
time frame: 21 days after injection
description: Immunogenicity will be assessed by Geometric mean titers (GMTs) of microneutralization (MN antibody on Days 0 and 21) antibodies against the vaccine strains and assessed by measuring Geometric mean fold rise and seroconversion rate. Cross-reactivity of antibodies induced by a single dose of the quadrivalent VLP vaccine will also be assessed and measured by HI and microneutralization (MN) antibody titers for heterologous influenza strains. This will be assessed using the measures of Geometric mean fold rise, seroconversion rate and seroprotection rate (for HI only).
arm group label: Low dose of quadrivalent VLP vaccine
arm group type: Experimental
description: A single low dose of quadrivalent VLP vaccine
arm group label: Medium dose of quadrivalent VLP vaccine
arm group type: Experimental
description: A single medium dose of quadrivalent VLP vaccine
arm group label: High dose of quadrivalent VLP vaccine
arm group type: Experimental
description: A single high dose of quadrivalent VLP vaccine
arm group label: Placebo
arm group type: Placebo Comparator
description: A single dose of Placebo
intervention type: Biological
intervention name: Low dose of quadrivalent VLP vaccine
description: A single low dose of quadrivalent VLP vaccine
arm group label: Low dose of quadrivalent VLP vaccine
intervention type: Biological
intervention name: Medium dose of quadrivalent VLP vaccine
description: A single medium dose of quadrivalent VLP vaccine
arm group label: Medium dose of quadrivalent VLP vaccine
intervention type: Biological
intervention name: High dose of quadrivalent VLP vaccine
description: A single high dose of quadrivalent VLP vaccine
arm group label: High dose of quadrivalent VLP vaccine
intervention type: Biological
intervention name: Placebo
description: A single dose of placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Sheldon, MD
role: Principal Investigator
affiliation: Miami Research Associate
last name: David J Seiden, MD
role: Principal Investigator
affiliation: Broward Research Group
facility: 
facility: 
country: United States
citation: Pillet S, Couillard J, Trepanier S, Poulin JF, Yassine-Diab B, Guy B, Ward BJ, Landry N. Immunogenicity and safety of a quadrivalent plant-derived virus like particle influenza vaccine candidate-Two randomized Phase II clinical trials in 18 to 49 and >/=50 years old adults. PLoS One. 2019 Jun 5;14(6):e0216533. doi: 10.1371/journal.pone.0216533. eCollection 2019.
PMID: 31166987
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Virus Diseases
mesh term: Influenza, Human
mesh term: Respiratory Tract Infections
mesh term: RNA Virus Infections
mesh term: Respiratory Tract Diseases
mesh term: Vaccines