<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/NCT02229357</url>
  </required_header>
  <id_info>
    <org_study_id>GPO Avian Flu Vaccine-Boost</org_study_id>
    <nct_id>NCT02229357</nct_id>
  </id_info>
  <brief_title>Evaluation of Priming Effects by PLAI Vaccine on the Subsequent Response to Inactivated H5N1 Vaccine</brief_title>
  <official_title>Evaluation of Priming Effects by Pandemic Live Attenuated Influenza Vaccine (LAIV Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2)) on the Subsequent Response to Inactivated H5N1 Vaccine in Healthy Thai Volunteers: A Non-Randomized, Open Label Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Government Pharmaceutical Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>World Health Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aim to compare immunogenicity of the inactivated H5 influenza vaccine single dose&#xD;
      between subjects previously vaccinated with LAIV H5N2 and naïve subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is a non-randomized, open label study to evaluate a licensed OrniFlu® inactivated vaccine&#xD;
      (produced by Microgen Russia) which will be given to healthy adult volunteers who&#xD;
      participated in a double blind placebo-controlled study Protocol No.: GPO AVIAN FLU&#xD;
      Vaccine-V02-2 at Vaccine Trial Centre and Department of Clinical Tropical Medicine, Faculty&#xD;
      of Tropical Medicine, Mahidol University in February to May 2013.&#xD;
&#xD;
      A total of 60 subjects, of whom 40 received two doses of LAIV H5N2 (prime-boost group), and&#xD;
      20 received placebo (control group) in the previous study will be asked to return to the&#xD;
      clinic to receive a single dose of an inactivated H5 influenza vaccine.&#xD;
&#xD;
      Total foloww up is 90 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects exhibiting sero-responses in each of the assays (HAI, microneutralization) in the prime-boost and the control groups.</measure>
    <time_frame>12 Months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-vaccination injection site and systemic reactogenicity and adverse events to the H5 inactivated influenza vaccine in subjects previously primed with LAIV H5N2 and in naïve subjects.</measure>
    <time_frame>12 Month</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Avian Influenza</condition>
  <arm_group>
    <arm_group_label>OrniFlu® inactivated vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>OrniFlu® inactivated vaccine</intervention_name>
    <description>All subjects will receive a single dose of an H5 inactivated influenza vaccine after blood collection for immunology assays</description>
    <arm_group_label>OrniFlu® inactivated vaccine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participated in the Phase II study Protocol No.: GPO AVIAN FLU Vaccine-V02-2&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Age 18-49 years old&#xD;
&#xD;
          -  Having Thai ID card or equivalent&#xD;
&#xD;
          -  Anti HIV - Negative&#xD;
&#xD;
          -  All hematology, biochemistry and urine analysis are within normal range or of no&#xD;
             clinical significance (not higher than 1.5 time of normal value without any clinical&#xD;
             finding from history and physical examination)&#xD;
&#xD;
          -  Able to read and write and sign written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known history of egg allergy&#xD;
&#xD;
          -  Having had recently influenza infection confirmed as H5&#xD;
&#xD;
          -  Receiving other vaccination against H5N1&#xD;
&#xD;
          -  History of bronchial asthma&#xD;
&#xD;
          -  History of chronic lung diseases&#xD;
&#xD;
          -  History of chronic rhinitis&#xD;
&#xD;
          -  History of immunodeficiency state&#xD;
&#xD;
          -  History of immunosuppression&lt; 6 months prior to immunization&#xD;
&#xD;
          -  History of heavy smoking (more than 5 packs per day)&#xD;
&#xD;
          -  History of alcoholic (pure drink 200 ml per day)&#xD;
&#xD;
          -  Acute infectious and noninfectious diseases (within 2 weeks)&#xD;
&#xD;
          -  HIV positives&#xD;
&#xD;
          -  The volunteers who have been taking immunoglobulin products or have had a blood&#xD;
             transfusion during past three months before the beginning of the experiment&#xD;
&#xD;
          -  Participation in other research study or stop participant less than 1 month&#xD;
&#xD;
          -  Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding&#xD;
&#xD;
          -  Poultry workers&#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>Punnee Pitisuttithum</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mahidol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>April 8, 2015</last_update_submitted>
  <last_update_submitted_qc>April 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mahidol University</investigator_affiliation>
    <investigator_full_name>Punnee Pitisuttithum</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>H5N2 Vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Influenza in Birds</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/NCT02229357
org study id: GPO Avian Flu Vaccine-Boost
nct id: NCT02229357
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This study aim to compare immunogenicity of the inactivated H5 influenza vaccine single dose
      between subjects previously vaccinated with LAIV H5N2 and naïve subjects
It is a non-randomized, open label study to evaluate a licensed OrniFlu® inactivated vaccine
      (produced by Microgen Russia) which will be given to healthy adult volunteers who
      participated in a double blind placebo-controlled study Protocol No.: GPO AVIAN FLU
      Vaccine-V02-2 at Vaccine Trial Centre and Department of Clinical Tropical Medicine, Faculty
      of Tropical Medicine, Mahidol University in February to May 2013.

      A total of 60 subjects, of whom 40 received two doses of LAIV H5N2 (prime-boost group), and
      20 received placebo (control group) in the previous study will be asked to return to the
      clinic to receive a single dose of an inactivated H5 influenza vaccine.

      Total foloww up is 90 days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Proportion of subjects exhibiting sero-responses in each of the assays (HAI, microneutralization) in the prime-boost and the control groups.
time frame: 12 Months
measure: Post-vaccination injection site and systemic reactogenicity and adverse events to the H5 inactivated influenza vaccine in subjects previously primed with LAIV H5N2 and in naïve subjects.
time frame: 12 Month
arm group label: OrniFlu® inactivated vaccine
arm group type: Experimental
intervention type: Biological
intervention name: OrniFlu® inactivated vaccine
description: All subjects will receive a single dose of an H5 inactivated influenza vaccine after blood collection for immunology assays
arm group label: OrniFlu® inactivated vaccine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Punnee Pitisuttithum
role: Principal Investigator
affiliation: Mahidol University
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Mahidol University
investigator full name: Punnee Pitisuttithum
investigator title: Professor
mesh term: Influenza, Human
mesh term: Influenza in Birds