<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/NCT02247362</url>
  </required_header>
  <id_info>
    <org_study_id>VAX2012Q-02</org_study_id>
    <nct_id>NCT02247362</nct_id>
  </id_info>
  <brief_title>Study of Safety and Immunogenicity of a Quadrivalent Influenza Vaccine in Healthy Adults Age 65-75 Years</brief_title>
  <official_title>Phase 1b/2 Double Blind, Randomized, Placebo Controlled Study of Safety and Immunogenicity of VAX2012Q: A Quadrivalent Influenza Vaccine in Healthy Adults Age 65-75 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VaxInnate Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VaxInnate Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      One dose of escalating strengths of an investigational influenza vaccine, VAX2012Q&#xD;
      (Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine), will be evaluated for&#xD;
      safety and immunogenicity in healthy adults 65 to 75 years of age in this placebo-controlled&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate, in a stepwise fashion, dose levels for an&#xD;
      investigational quadrivalent influenza vaccine containing 2 influenza A strains and 2&#xD;
      influenza B strains. This is a multi-center, randomized, double-blind, placebo-controlled,&#xD;
      dose escalating study in which up to 200 healthy adults age 65-75 years will be administered&#xD;
      a single dose of either placebo or an investigational influenza vaccine (VAX2012Q,&#xD;
      Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine) at one of up to 3 dose&#xD;
      levels. Fifty or up to 75 subjects will be enrolled in each dose level. Data for safety and&#xD;
      immunogenicity will be collected for all dose levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">March 2016</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Phase 1/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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Injection site and systemic symptoms will be collected for 21 days after vaccination. Other AEs assessed as related to vaccination will be collected at a 6 month and 1 year phone call.</measure>
    <time_frame>21 days post-immunization; follow up at 6 months and one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immune response to vaccine will be measured by serum HAI levels</measure>
    <time_frame>21 days post-immunization</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Vaccine Dose Group 12 mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VAX2012Q, 12 mcg dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaccine Dose Group 20 mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VAX2012Q, 20 mcg dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaccine Dose Group 16 mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VAX2012Q; 16 mcg dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaccine Diluent</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vaccine Diluent, F147, as placebo control</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VAX2012Q</intervention_name>
    <description>Recombinant influenza HA vaccine consisting of two Influenza A subtypes and two Influenza B lineages and delivered IM</description>
    <arm_group_label>Vaccine Dose Group 12 mcg</arm_group_label>
    <arm_group_label>Vaccine Dose Group 16 mcg</arm_group_label>
    <arm_group_label>Vaccine Dose Group 20 mcg</arm_group_label>
    <other_name>Quadrivalent Recombinant Hemagglutinin Influenza Vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Vaccine Diluent</description>
    <arm_group_label>Vaccine Diluent</arm_group_label>
    <other_name>Vaccine Diluent</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females aged 65-75 years of age at the time of vaccination in good health.&#xD;
             Individuals that are stably treated for hypertension may be eligible.&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Willing to receive the unlicensed vaccine&#xD;
&#xD;
          -  Willing to provide multiple blood specimens&#xD;
&#xD;
          -  Live in the community, independently or in an assisted living environment&#xD;
&#xD;
          -  Based on the results of the Short Portable Mental Status Questionnaire be rated as&#xD;
             normal or have no greater than mild severity dementia&#xD;
&#xD;
          -  As defined by the Canadian Study of Health and Aging Clinical Frailty Scale be a Class&#xD;
             1 to 5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preceding the administration of study vaccine, has received or will receive 1) any&#xD;
             licensed or investigational influenza vaccine product within 6 months, 2) any&#xD;
             investigational drug or any investigational vaccine product other than influenza&#xD;
             vaccine within the 30 days, 3) any licensed live vaccine other than influenza vaccine&#xD;
             within 4 weeks, 4) any licensed inactivated vaccine other than influenza vaccine&#xD;
             within 2 weeks&#xD;
&#xD;
          -  Planned receipt before the Day 21 blood draw of 1) any licensed or investigational&#xD;
             influenza vaccine product, 2) any investigational drug or any investigational vaccine&#xD;
             product other than influenza vaccine, 3) any licensed live vaccine other than&#xD;
             influenza vaccine, 4) any licensed inactivated vaccine other than influenza vaccine&#xD;
&#xD;
          -  History of excessive alcohol use, drug abuse or significant psychiatric illness&#xD;
&#xD;
          -  Has a chronic illness that is not medically stable, is receiving a concomitant therapy&#xD;
             in which the medication dose has not been stable for at least 3 weeks prior to&#xD;
             immunization or has any other condition that could interfere with the subject's&#xD;
             participation in the study or interpretation of the study results&#xD;
&#xD;
          -  Clinically significant abnormal liver function tests at screening&#xD;
&#xD;
          -  Subjects with Grade 2 or higher abnormalities in total bilirubin at screening&#xD;
&#xD;
          -  Subjects with any of the following laboratory abnormalities at screening: Creatinine&#xD;
             &gt;1.7mg/dL, Hemoglobin &lt; 11g/dL for females; &lt;12.5 g/dL for males, WBC &lt;2500cell/mm3 or&#xD;
             &gt; 15,000cell/mm3 and Platelet Count &lt;125,000cell/mm3&#xD;
&#xD;
          -  Positive serology of HBSAg, HCV or HIV antibodies&#xD;
&#xD;
          -  Having cancer or have received treatment for cancer within three years, excluding&#xD;
             minor skin cancers, which are allowed unless located at the vaccination site. Persons&#xD;
             with a history of cancer who are disease-free without treatment for three years or&#xD;
             more are eligible.&#xD;
&#xD;
          -  Persons with impaired immune responsiveness (of any cause), including Type 1 diabetes&#xD;
             mellitus and auto immune disorders or any known or suspected autoimmune disease&#xD;
&#xD;
          -  Persons with congenital immunodeficiency or history of acquired immunodeficiency, or&#xD;
             immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within&#xD;
             the preceding six months.&#xD;
&#xD;
          -  Persons with a history of severe allergic reaction after previous vaccinations or&#xD;
             hypersensitivity to any seasonal influenza vaccine component&#xD;
&#xD;
          -  Persons with a history of Guillain-Barré Syndrome&#xD;
&#xD;
          -  Receipt or donation of blood or blood products 8 weeks prior to vaccination or during&#xD;
             the three week study period following vaccination&#xD;
&#xD;
          -  Acute disease within 72 hours prior to vaccination.&#xD;
&#xD;
          -  An oral temperature &gt;100.4°F (38°C)&#xD;
&#xD;
          -  Systolic blood pressure &lt; 85 mm Hg and subjects whose hypertension is untreated or&#xD;
             unstable with antihypertensive therapy or that have systolic BP ≥ 160 mm Hg or&#xD;
             diastolic BP ≥ 100 mm Hg requiring medical intervention with more than one drug or&#xD;
             more intensive therapy than previously used or indicated.&#xD;
&#xD;
          -  Body Mass Index &gt;40&#xD;
&#xD;
          -  Disorders of coagulation&#xD;
&#xD;
          -  Women less than 1 year post menopausal&#xD;
&#xD;
          -  A clinical diagnosis of influenza within the previous 6 months&#xD;
&#xD;
          -  Any other condition or circumstance which, in the opinion of the Principal&#xD;
             Investigator, poses an unacceptable risk for participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lynda Tussey, PHD</last_name>
    <role>Study Director</role>
    <affiliation>VaxInnate Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Q-Pharm Pty Limited</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4006</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CMAX, a division of IDT Australia Limited</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Linear Clinical Research Limited</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>April 16, 2015</last_update_submitted>
  <last_update_submitted_qc>April 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Safety</keyword>
  <keyword>Immunogenicity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemagglutinins</mesh_term>
    <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/NCT02247362
org study id: VAX2012Q-02
nct id: NCT02247362
lead sponsor: 
has dmc: Yes
One dose of escalating strengths of an investigational influenza vaccine, VAX2012Q
      (Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine), will be evaluated for
      safety and immunogenicity in healthy adults 65 to 75 years of age in this placebo-controlled
      study.
The purpose of this study is to evaluate, in a stepwise fashion, dose levels for an
      investigational quadrivalent influenza vaccine containing 2 influenza A strains and 2
      influenza B strains. This is a multi-center, randomized, double-blind, placebo-controlled,
      dose escalating study in which up to 200 healthy adults age 65-75 years will be administered
      a single dose of either placebo or an investigational influenza vaccine (VAX2012Q,
      Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine) at one of up to 3 dose
      levels. Fifty or up to 75 subjects will be enrolled in each dose level. Data for safety and
      immunogenicity will be collected for all dose levels.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Injection site and systemic symptoms will be collected for 21 days after vaccination. Other AEs assessed as related to vaccination will be collected at a 6 month and 1 year phone call.
time frame: 21 days post-immunization; follow up at 6 months and one year
measure: Immune response to vaccine will be measured by serum HAI levels
time frame: 21 days post-immunization
arm group label: Vaccine Dose Group 12 mcg
arm group type: Experimental
description: VAX2012Q, 12 mcg dose
arm group label: Vaccine Dose Group 20 mcg
arm group type: Experimental
description: VAX2012Q, 20 mcg dose
arm group label: Vaccine Dose Group 16 mcg
arm group type: Experimental
description: VAX2012Q; 16 mcg dose
arm group label: Vaccine Diluent
arm group type: Placebo Comparator
description: Vaccine Diluent, F147, as placebo control
intervention type: Biological
intervention name: VAX2012Q
description: Recombinant influenza HA vaccine consisting of two Influenza A subtypes and two Influenza B lineages and delivered IM
arm group label: Vaccine Dose Group 12 mcg
arm group label: Vaccine Dose Group 16 mcg
arm group label: Vaccine Dose Group 20 mcg
other name: Quadrivalent Recombinant Hemagglutinin Influenza Vaccine
intervention type: Other
intervention name: Placebo
description: Vaccine Diluent
arm group label: Vaccine Diluent
other name: Vaccine Diluent
criteria: 
gender: All
minimum age: 65 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lynda Tussey, PHD
role: Study Director
affiliation: VaxInnate Corporation
facility: 
facility: 
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Hemagglutinins
mesh term: Vaccines