<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/NCT03016143</url>
  </required_header>
  <id_info>
    <org_study_id>VSI-II-01/2016</org_study_id>
    <nct_id>NCT03016143</nct_id>
  </id_info>
  <brief_title>Immunogenicity and Safety Study of Allantoic Split Inactivated Seasonal Influenza Vaccine (VSI)</brief_title>
  <official_title>A Randomized, Blinded, Comparative Study of Phase II Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Research Institute for Biological Safety Problems</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Asfendiyarov Kazakh National Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Research Institute of Influenza, Russia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Research Institute for Biological Safety Problems</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a single centre, phase II, double-blind, randomized, comparative trial that&#xD;
      explored the immunogenicity and safety of single dose a allantoic split inactivated seasonal&#xD;
      influenza vaccine and VAXIGRIP vacccine in healthy adults the two age groups (in persons 18&#xD;
      to 60 years of age and older than 60 years).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</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>Geometric Mean Fold Increase in HI Antibody Titer</measure>
    <time_frame>Change from Baseline HI Antibody Titer at 21 days</time_frame>
    <description>Geometric mean fold increase in HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer</measure>
    <time_frame>Change from Baseline HI Antibody Titer at 21 days</time_frame>
    <description>Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer &lt;10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroprotection Rate of HI Antibody Titer</measure>
    <time_frame>Change from Baseline HI Antibody Titer at 21 days</time_frame>
    <description>Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)</measure>
    <time_frame>21 Days</time_frame>
    <description>Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)</measure>
    <time_frame>21 Days</time_frame>
    <description>Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs</measure>
    <time_frame>21 Days</time_frame>
    <description>The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events (SAEs), including abnormal laboratory findings</measure>
    <time_frame>21 Days</time_frame>
    <description>Serious adverse events (SAEs) are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Group #1 (Allantoic Split Inactivated Seasonal flu Vaccine)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 volunteers aged 18 to 60 years, which introduced the vaccine allantoic split inactivated seasonal influenza</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group #2 (Allantoic Split Inactivated Seasonal flu Vaccine)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 volunteers over the age of 60 years, which introduced the vaccine allantoic split inactivated seasonal influenza</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group #3 (Vaccine VAXIGRIP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 volunteers aged 18 to 60 years, which introduced vaccine VAXIGRIP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group #4 (Vaccine VAXIGRIP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 volunteers over the age of 60 years, which introduced vaccine VAXIGRIP</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Allantoic Split Inactivated Seasonal flu Vaccine</intervention_name>
    <description>Allantoic split inactivated seasonal influenza vaccine has been prepared on eggs and is made from inactivated parts of the following influenza virus strains: NIBRG-121xp (A/California/7/2009 (H1N1)v and А/PR/8/34 (H1N1)), NYMC X-217 (A/ Victoria/361/2011(H3N2) and А/PR/8/34 (H1N1)), NYMC BX-49 (B/Texas/06/2011 (Yamagata lineage) - like High Yield Reassortant (1:1:6) With B/Lee/40 NP, B/Panama/45/90 NS genes).</description>
    <arm_group_label>Group #1 (Allantoic Split Inactivated Seasonal flu Vaccine)</arm_group_label>
    <arm_group_label>Group #2 (Allantoic Split Inactivated Seasonal flu Vaccine)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VAXIGRIP</intervention_name>
    <description>Vaxigrip - Seasonal Influenza, split virion, inactivated vaccine. Sanofi Pasteur Serial Number N3E681V</description>
    <arm_group_label>Group #3 (Vaccine VAXIGRIP)</arm_group_label>
    <arm_group_label>Group #4 (Vaccine VAXIGRIP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  volunteers (men and women) aged 18 years and older.&#xD;
&#xD;
          -  Literate and willing to provide written informed consent.&#xD;
&#xD;
          -  A signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Available in anamnaze volunteer at any allergic reactions.&#xD;
&#xD;
          -  Allergic reactions to chicken proteins, or any preceding vaccination.&#xD;
&#xD;
          -  Acute illness with a fever (37.0 C).&#xD;
&#xD;
          -  Vaccination against influenza in the 2015/2016 season.&#xD;
&#xD;
          -  Current or recent (within two weeks of enrollment) acute respiratory illness with or&#xD;
             without fever.&#xD;
&#xD;
          -  Hypersensitivity after previous administration of any vaccine.&#xD;
&#xD;
          -  History of chronic alcohol abuse and/or illegal drug use.&#xD;
&#xD;
          -  Any clinically significant abnormal laboratory finding.&#xD;
&#xD;
          -  A positive pregnancy test for all women of childbearing potential.&#xD;
&#xD;
          -  Administration of immunosuppressive drugs or other immune modifying drugs within 4&#xD;
             weeks prior to study enrollment.&#xD;
&#xD;
          -  Acute or chronic clinically significant pulmonary disease, cardiovascular disease,&#xD;
             gastrointestinal disease, liver disease, neurological illness, liver disease, blood&#xD;
             disease, skin disorder, endocrine disorder, neurological illness and psychiatric&#xD;
             disorder as determined by medical history, physical examination or clinical laboratory&#xD;
             screening tests, which in the opinion of the investigator, might interfere with the&#xD;
             study objectives.&#xD;
&#xD;
          -  History of leukemia or any other blood or solid organ cancer.&#xD;
&#xD;
          -  Receipt of antivirals, antibiotics, immunoglobulins or other blood products within 4&#xD;
             weeks prior to study enrollment or planned receipt of such products during the period&#xD;
             of subject participation in the study.&#xD;
&#xD;
          -  Participation in another clinical trial within the previous three months or planned&#xD;
             enrollment in such a trial during the period of this study.&#xD;
&#xD;
          -  Subjects who are, in the opinion of the investigator, at significantly increased risk&#xD;
             of non-cooperation with requirements of the study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Berik M Khairullin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Institute for Biological Safety Problems</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kazakh National Medical University</name>
      <address>
        <city>Almaty</city>
        <zip>050000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kazakhstan</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>June 6, 2018</last_update_submitted>
  <last_update_submitted_qc>June 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>phase II</keyword>
  <keyword>split</keyword>
  <keyword>vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03016143
org study id: VSI-II-01/2016
nct id: NCT03016143
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The study is a single centre, phase II, double-blind, randomized, comparative trial that
      explored the immunogenicity and safety of single dose a allantoic split inactivated seasonal
      influenza vaccine and VAXIGRIP vacccine in healthy adults the two age groups (in persons 18
      to 60 years of age and older than 60 years).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Geometric Mean Fold Increase in HI Antibody Titer
time frame: Change from Baseline HI Antibody Titer at 21 days
description: Geometric mean fold increase in HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.
measure: Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer
time frame: Change from Baseline HI Antibody Titer at 21 days
description: Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer <10.
measure: Seroprotection Rate of HI Antibody Titer
time frame: Change from Baseline HI Antibody Titer at 21 days
description: Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.
measure: Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
time frame: 21 Days
description: Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting.
measure: Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
time frame: 21 Days
description: Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
measure: Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
time frame: 21 Days
description: The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.
measure: Serious adverse events (SAEs), including abnormal laboratory findings
time frame: 21 Days
description: Serious adverse events (SAEs) are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
arm group label: Group #1 (Allantoic Split Inactivated Seasonal flu Vaccine)
arm group type: Active Comparator
description: 100 volunteers aged 18 to 60 years, which introduced the vaccine allantoic split inactivated seasonal influenza
arm group label: Group #2 (Allantoic Split Inactivated Seasonal flu Vaccine)
arm group type: Active Comparator
description: 100 volunteers over the age of 60 years, which introduced the vaccine allantoic split inactivated seasonal influenza
arm group label: Group #3 (Vaccine VAXIGRIP)
arm group type: Experimental
description: 50 volunteers aged 18 to 60 years, which introduced vaccine VAXIGRIP
arm group label: Group #4 (Vaccine VAXIGRIP)
arm group type: Experimental
description: 50 volunteers over the age of 60 years, which introduced vaccine VAXIGRIP
intervention type: Biological
intervention name: Allantoic Split Inactivated Seasonal flu Vaccine
description: Allantoic split inactivated seasonal influenza vaccine has been prepared on eggs and is made from inactivated parts of the following influenza virus strains: NIBRG-121xp (A/California/7/2009 (H1N1)v and А/PR/8/34 (H1N1)), NYMC X-217 (A/ Victoria/361/2011(H3N2) and А/PR/8/34 (H1N1)), NYMC BX-49 (B/Texas/06/2011 (Yamagata lineage) - like High Yield Reassortant (1:1:6) With B/Lee/40 NP, B/Panama/45/90 NS genes).
arm group label: Group #1 (Allantoic Split Inactivated Seasonal flu Vaccine)
arm group label: Group #2 (Allantoic Split Inactivated Seasonal flu Vaccine)
intervention type: Biological
intervention name: VAXIGRIP
description: Vaxigrip - Seasonal Influenza, split virion, inactivated vaccine. Sanofi Pasteur Serial Number N3E681V
arm group label: Group #3 (Vaccine VAXIGRIP)
arm group label: Group #4 (Vaccine VAXIGRIP)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Berik M Khairullin, PhD
role: Principal Investigator
affiliation: Research Institute for Biological Safety Problems
facility: 
country: Kazakhstan
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: Undecided