<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/NCT01701752</url>
  </required_header>
  <id_info>
    <org_study_id>FP-01.1_CS_03</org_study_id>
    <nct_id>NCT01701752</nct_id>
  </id_info>
  <brief_title>Influenza A Vaccine (FP-01.1) Formulated With and Without Adjuvant, in the Presence or Absence of a Single Administration of a Trivalent Inactivated Influenza Virus Vaccine in Older Adults</brief_title>
  <official_title>A Randomised, Double Blind, Double Observer Study to Assess Repeated Administration of a Single Dose of an Influenza A Vaccine (FP-01.1) Formulated With and Without Adjuvant, in the Presence or Absence of a Single Dose of a Trivalent Inactivated Influenza Virus Vaccine in Subjects 65 to 74 Years of Age.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Immune Targeting Systems Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Immune Targeting Systems Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the safety and immunogenicity of FP-01.1 and FP-01.1 reformulated&#xD;
      with an adjuvant (FP-01.1-Adjuvant) in relatively healthy subjects 65 to 74 years of age,&#xD;
      subjects that are more representative of the target population. Both formulations will be&#xD;
      administered alone or concomitantly with the Trivalent Inactivated Influenza Virus (TIV)&#xD;
      vaccine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Phase 1</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number and proportion of subjects reporting solicited local reactions and severity of the local reactions</measure>
    <time_frame>Day 1- 209</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>To assess and compare the immunogenicity response between groups</measure>
    <time_frame>Day 1- 209</time_frame>
    <description>The immunogenicity of two different formulations of FP-01.1 after each vaccine injection in each treated group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and proportion of subjects reporting unsolicited AEs and Serious Adverse Events (SAEs)</measure>
    <time_frame>Day 1- 209</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and proportion of subjects with abnormal haematology, blood chemistry lab assessments</measure>
    <time_frame>Day 1- 209</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and proportion of subjects with abnormal vital signs/ECG assessments</measure>
    <time_frame>Day 1 - 209</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exploratory immunogenicity tests on samples obtained from subjects</measure>
    <time_frame>Day 1 -209</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the impact of FP-01.1 and FP-01.1-Adjuvant on the immune response to TIV</measure>
    <time_frame>Day 1-209</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Influenza A</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 1: FP-01.1 + Placebo ; Day 29: FP-01.1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 1: FP-01.1 + TIV ; Day 29: FP-01.1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 1: FP-01.1-Adjuvant + Placebo ; Day 29: FP-01.1-Adjuvant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 1: FP-01.1-Adjuvant + TIV ; Day 29: FP-01.1-Adjuvant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 1: Adjuvant + TIV ; Day 29: Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 6</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 1: Placebo + TIV ; Day 29: Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FP-01.1 + Placebo</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FP-01.1 + TIV</intervention_name>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FP-01.1-Adjuvant + Placebo</intervention_name>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FP-01.1-Adjuvant + TIV</intervention_name>
    <arm_group_label>Group 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Adjuvant + TIV</intervention_name>
    <arm_group_label>Group 5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo + TIV</intervention_name>
    <arm_group_label>Group 6</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FP-01.1</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FP-01.1-Adjuvant</intervention_name>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Group 5</arm_group_label>
    <arm_group_label>Group 6</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 65 to 74 years inclusive at the time of consent&#xD;
&#xD;
          -  Female subjects will be post-menopausal (no menses for at least 2 years) and therefore&#xD;
             of non-child bearing potential&#xD;
&#xD;
          -  Male subjects willing to comply with the applicable contraceptive requirements of the&#xD;
             protocol, e.g. must agree to refrain from fathering a child until after the safety&#xD;
             follow up visit. Male subjects do not need to use contraception if their partner has&#xD;
             been through the menopause, or has had a hysterectomy or bilateral oophorectomy. If a&#xD;
             male subject's partner is of child bearing potential, male subjects must agree to use&#xD;
             a barrier method (condom) as a method of birth control in addition to any&#xD;
             contraceptive measures normally taken by his partner, until after the safety follow up&#xD;
             visit.&#xD;
&#xD;
          -  Satisfactory medical assessment with no clinically significant or relevant&#xD;
             abnormalities in medical history, physical examination, vital signs, ECG and&#xD;
             laboratory evaluation (haematology &amp; biochemistry) as assessed by the Investigator in&#xD;
             relation to the age of the patient.&#xD;
&#xD;
          -  An understanding, ability and willingness to fully comply with study procedures and&#xD;
             restrictions&#xD;
&#xD;
          -  Ability to provide written, personally signed and dated informed consent to&#xD;
             participate in the study.&#xD;
&#xD;
          -  The subject has a BMI &lt; 35.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  As a result of the medical screening process, the Principal Investigator or Co-&#xD;
             Investigator considers the subject unfit for the study.&#xD;
&#xD;
          -  Women of child-bearing potential&#xD;
&#xD;
          -  Clinically significant , uncontrolled, current, chronic or recurrent disease, as&#xD;
             deemed by the Investigator, (e.g. cardiovascular, respiratory, endocrine, renal,&#xD;
             liver, gastrointestinal, autoimmune, immune suppression, malignancy or other&#xD;
             conditions) that could affect the action, absorption or disposition of the IMP or&#xD;
             could affect clinical or laboratory assessments.&#xD;
&#xD;
          -  Significant illness as judged by the Principal Investigator or Co-Investigator within&#xD;
             2 weeks of the first dose of IMP.&#xD;
&#xD;
          -  Subjects with a history of allergies or allergic conditions including anaphylactic&#xD;
             reactions, asthmatics, hay fever, allergy to egg products and eczema sufferers&#xD;
             requiring medication which in the opinion of the Principal Investigator or Co-&#xD;
             Investigator will affect their participation in the study.&#xD;
&#xD;
          -  Subjects receiving medications that affect the immune system including systemic&#xD;
             steroids at a dose greater than 5mg and patients on chronic medications where the dose&#xD;
             has not been stable for at least 3 months. Inhaled or topical steroids will be&#xD;
             allowed.&#xD;
&#xD;
          -  Known or suspected intolerance or hypersensitivity to the IMP, or closely related&#xD;
             compounds or any of the stated ingredients.&#xD;
&#xD;
          -  Male subjects who consume more than 21 units of alcohol per week and female subjects&#xD;
             who consume more than 14 units of alcohol per week.&#xD;
&#xD;
          -  A positive HIV antibody screen, Hepatitis B surface antigen, Hepatitis B core&#xD;
             antibody, or Hepatitis C antibody screen&#xD;
&#xD;
          -  Subjects who have significant scarring, tattoos, abrasions, cuts or infections, that&#xD;
             in the opinion of the Investigator could interfere with evaluation of injection site&#xD;
             local reactions, over the deltoid region of both arms as these will be the dose site.&#xD;
&#xD;
          -  Donation of blood or blood products (e.g. plasma, platelets) within 90 days prior to&#xD;
             or intention to donate blood during the entire study.&#xD;
&#xD;
          -  Use of another investigational medicinal product within 90 days prior to receiving the&#xD;
             first dose of IMP or intention to enrol in another clinical study throughout the&#xD;
             entire study including the follow up period.&#xD;
&#xD;
          -  Subject with suspected recent (≤6 months) experience of influenza-like illness (fever&#xD;
             [&gt;37.8ºC] and cough and/or sore throat &gt; 2 days- in the absence of a known cause other&#xD;
             than influenza)&#xD;
&#xD;
          -  Subjects who have received a flu vaccine in the last 6 months&#xD;
&#xD;
          -  Any clinically significant abnormalities, in the opinion of the Principal Investigator&#xD;
             or Co-Investigator, on electrocardiograms (ECGs)&#xD;
&#xD;
          -  In addition, for each subject, a completed medical history questionnaire will be taken&#xD;
             as part of the consented study procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Geert Leroux-Roels, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Vaccinology, Ghent University Hospital</affiliation>
  </overall_official>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>July 26, 2013</last_update_submitted>
  <last_update_submitted_qc>July 26, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza A</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_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/NCT01701752
org study id: FP-01.1_CS_03
nct id: NCT01701752
lead sponsor: 
has dmc: Yes
This study will evaluate the safety and immunogenicity of FP-01.1 and FP-01.1 reformulated
      with an adjuvant (FP-01.1-Adjuvant) in relatively healthy subjects 65 to 74 years of age,
      subjects that are more representative of the target population. Both formulations will be
      administered alone or concomitantly with the Trivalent Inactivated Influenza Virus (TIV)
      vaccine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number and proportion of subjects reporting solicited local reactions and severity of the local reactions
time frame: Day 1- 209
measure: To assess and compare the immunogenicity response between groups
time frame: Day 1- 209
description: The immunogenicity of two different formulations of FP-01.1 after each vaccine injection in each treated group
measure: Number and proportion of subjects reporting unsolicited AEs and Serious Adverse Events (SAEs)
time frame: Day 1- 209
measure: Number and proportion of subjects with abnormal haematology, blood chemistry lab assessments
time frame: Day 1- 209
measure: Number and proportion of subjects with abnormal vital signs/ECG assessments
time frame: Day 1 - 209
measure: Exploratory immunogenicity tests on samples obtained from subjects
time frame: Day 1 -209
measure: To assess the impact of FP-01.1 and FP-01.1-Adjuvant on the immune response to TIV
time frame: Day 1-209
arm group label: Group 1
arm group type: Active Comparator
description: Day 1: FP-01.1 + Placebo ; Day 29: FP-01.1
arm group label: Group 2
arm group type: Active Comparator
description: Day 1: FP-01.1 + TIV ; Day 29: FP-01.1
arm group label: Group 3
arm group type: Active Comparator
description: Day 1: FP-01.1-Adjuvant + Placebo ; Day 29: FP-01.1-Adjuvant
arm group label: Group 4
arm group type: Active Comparator
description: Day 1: FP-01.1-Adjuvant + TIV ; Day 29: FP-01.1-Adjuvant
arm group label: Group 5
arm group type: Active Comparator
description: Day 1: Adjuvant + TIV ; Day 29: Placebo
arm group label: Group 6
arm group type: Active Comparator
description: Day 1: Placebo + TIV ; Day 29: Placebo
intervention type: Biological
intervention name: FP-01.1 + Placebo
arm group label: Group 1
intervention type: Biological
intervention name: FP-01.1 + TIV
arm group label: Group 2
intervention type: Biological
intervention name: FP-01.1-Adjuvant + Placebo
arm group label: Group 3
intervention type: Biological
intervention name: FP-01.1-Adjuvant + TIV
arm group label: Group 4
intervention type: Biological
intervention name: Adjuvant + TIV
arm group label: Group 5
intervention type: Biological
intervention name: Placebo + TIV
arm group label: Group 6
intervention type: Biological
intervention name: FP-01.1
arm group label: Group 1
arm group label: Group 2
intervention type: Biological
intervention name: FP-01.1-Adjuvant
arm group label: Group 3
arm group label: Group 4
intervention type: Other
intervention name: Placebo
arm group label: Group 5
arm group label: Group 6
criteria: 
gender: All
minimum age: 65 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Geert Leroux-Roels, Professor
role: Principal Investigator
affiliation: Centre for Vaccinology, Ghent University Hospital
responsible party type: Sponsor
mesh term: Influenza, Human