<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/NCT01666262</url>
  </required_header>
  <id_info>
    <org_study_id>GPO FLU VACCINE-01</org_study_id>
    <nct_id>NCT01666262</nct_id>
  </id_info>
  <brief_title>Phase I/II Safety and Immunogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) in Healthy Thais</brief_title>
  <official_title>Phase I/II Safety and Immunogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) in Healthy Thais</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate safety and reactogenicity of Pandemic Live&#xD;
      Attenuated Influenza Vaccine (PLAIV) manufactured by GPO, Thailand, and to evaluate humoral&#xD;
      immune response of the above vaccine after intranasal application by using HAI test, micro&#xD;
      neutralization assays.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Part A: 24 volunteers will be enrolled and divided into 2 groups -12 volunteers in each of 2&#xD;
      groups receiving either 5.0-6.5 log 10 EID50 or 6.6-7.5 log10 EID50 respectively. 9 who will&#xD;
      received vaccine vaccine strain and 3 who will received placebo.&#xD;
&#xD;
      Part B: Total 324 participants will randomized into 2 group using 3:1 ratio (300 vaccines:100&#xD;
      placebos). There are 3 stratified age groups: &gt;12-18 years, &gt;18-49 years and &gt;49 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">January 2012</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Systemic reaction and local reaction (vital sign, temperature)</measure>
    <time_frame>11/2 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Humoral immune response</measure>
    <time_frame>11/2 year</time_frame>
    <description>Peak immunogenicity blood specimen and nasal washing for accessing immune response IgA.&#xD;
Nasal swab on D2, D3, D5, D7 after immunization. Blood for ASC assay at D0 (baseline) and D7 after each dose of vaccine.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">363</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>A/17/CA/2009/38 (H1N1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Stabilizer</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Vaccine A/17/CA/2009/38 (H1N1)</intervention_name>
    <description>Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1)</description>
    <arm_group_label>A/17/CA/2009/38 (H1N1)</arm_group_label>
    <other_name>GPO Flu Vaccine-01</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo:Stabilizer</intervention_name>
    <description>5% sucrose</description>
    <arm_group_label>Stabilizer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Age 9 - &gt;49 years old&#xD;
&#xD;
          -  Having Thai ID card or equivalent&#xD;
&#xD;
          -  Are seronegative to the specific H1N1 influenza virus determined by antibody titer&#xD;
             less than 1:10 by HAI test to the corresponding antigen&#xD;
&#xD;
          -  Anti HIV - Negative&#xD;
&#xD;
          -  All hematology &amp; biochemistry within normal range&#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 H1N1 (indeed all other types if&#xD;
             Influenza and vaccination with seasonal vaccine will not interfere)&#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&#xD;
&#xD;
          -  Acute infectious and noninfectious diseases (within 2 weeks)&#xD;
&#xD;
          -  Exacerbation of chronic diseases or cancer or HIV positives&#xD;
&#xD;
          -  Anamnestic leukocytosis, hepatitis B and C 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&#xD;
&#xD;
          -  Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding&#xD;
&#xD;
          -  Any concomitant medication with Aspirin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prof.Punnee Pitisuttithum, MBBS,DTM&amp;HDipGrad</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mahidol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>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>August 2012</verification_date>
  <study_first_submitted>January 11, 2010</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>August 10, 2012</last_update_submitted>
  <last_update_submitted_qc>August 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 16, 2012</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>FLU</keyword>
  <keyword>H1N1</keyword>
  <keyword>GPO</keyword>
  <keyword>PLAIV</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>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/NCT01666262
org study id: GPO FLU VACCINE-01
nct id: NCT01666262
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate safety and reactogenicity of Pandemic Live
      Attenuated Influenza Vaccine (PLAIV) manufactured by GPO, Thailand, and to evaluate humoral
      immune response of the above vaccine after intranasal application by using HAI test, micro
      neutralization assays.
Part A: 24 volunteers will be enrolled and divided into 2 groups -12 volunteers in each of 2
      groups receiving either 5.0-6.5 log 10 EID50 or 6.6-7.5 log10 EID50 respectively. 9 who will
      received vaccine vaccine strain and 3 who will received placebo.

      Part B: Total 324 participants will randomized into 2 group using 3:1 ratio (300 vaccines:100
      placebos). There are 3 stratified age groups: >12-18 years, >18-49 years and >49 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Systemic reaction and local reaction (vital sign, temperature)
time frame: 11/2 year
measure: Humoral immune response
time frame: 11/2 year
description: Peak immunogenicity blood specimen and nasal washing for accessing immune response IgA.
Nasal swab on D2, D3, D5, D7 after immunization. Blood for ASC assay at D0 (baseline) and D7 after each dose of vaccine.
arm group label: A/17/CA/2009/38 (H1N1)
arm group type: Experimental
arm group label: Stabilizer
arm group type: Placebo Comparator
intervention type: Biological
intervention name: Vaccine A/17/CA/2009/38 (H1N1)
description: Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1)
arm group label: A/17/CA/2009/38 (H1N1)
other name: GPO Flu Vaccine-01
intervention type: Other
intervention name: Placebo:Stabilizer
description: 5% sucrose
arm group label: Stabilizer
criteria: 
gender: All
minimum age: 9 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Prof.Punnee Pitisuttithum, MBBS,DTM&HDipGrad
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: Vaccines