<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/NCT04448132</url>
  </required_header>
  <id_info>
    <org_study_id>VIPV-07 E2</org_study_id>
    <nct_id>NCT04448132</nct_id>
  </id_info>
  <brief_title>Evaluation of Persistence of Immunity in 4-year-old Children Previously Immunised With IPV-Al AJV (Picovax®)</brief_title>
  <official_title>Evaluation of the Persistence of the Immunity in 4-year-old Children Previously Immunised With an Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al AJV (Picovax®) by Measuring the Response to an Additional Dose of IPV-Al AJV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AJ Vaccines A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AJ Vaccines A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The trial is a phase 4, open-label, multicentre clinical trial with healthy subjects who have&#xD;
      been vaccinated with IPV-Al AJV at 2, 4, 6 and 15 18 months of age in previous trials. Levels&#xD;
      of antibodies against poliovirus types 1, 2 and 3 after immunisation with IPV Al AJV will be&#xD;
      measured in the trial subjects at the age of 4 years. An additional IPV-Al AJV dose&#xD;
      (investigational vaccine) will be administered and the booster response to IPV-Al AJV will be&#xD;
      investigated one month after administration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2020</start_date>
  <completion_date type="Actual">May 3, 2021</completion_date>
  <primary_completion_date type="Actual">May 3, 2021</primary_completion_date>
  <phase>Phase 4</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>Seroprotection (titer ≥8) against poliovirus types 1, 2 and 3</measure>
    <time_frame>One month after administration of an additional dose of IPV-Al AJV</time_frame>
    <description>Individual serum titers against poliovirus types 1, 2 and three will be measured in collected serum samples</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">163</enrollment>
  <condition>Poliomyelitis</condition>
  <arm_group>
    <arm_group_label>IPV-Al AJV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One dose of 0.5 mL of IPV-Al AJV injected intramuscularly perpendicular to the skin in the RIGHT deltoid muscle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IPV-Al</intervention_name>
    <description>adjuvanted reduced dose inactivated polio vaccine</description>
    <arm_group_label>IPV-Al AJV</arm_group_label>
    <other_name>Picovax®</other_name>
    <other_name>IPV-Al AJV</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children that have been vaccinated with IPV-Al AJV in the VIPV-07 and VIPV-07 E1&#xD;
             trials and have completed these trials&#xD;
&#xD;
          2. Healthy, as assessed from medical history and physical examination&#xD;
&#xD;
          3. Parent(s)/guardian(s), according to the local legal requirements, have been properly&#xD;
             informed about the trial and have signed the informed consent form&#xD;
&#xD;
          4. Parent(s)/guardian(s), according to the local legal requirements, have been granted&#xD;
             access to the child´s trial related medical records&#xD;
&#xD;
          5. Parent(s)/guardian(s), according to the local legal requirements, are likely to comply&#xD;
             with trial procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous vaccination with OPV&#xD;
&#xD;
          2. Previous vaccination with IPV outside the VIPV-07 and VIPV-07 E1 trials&#xD;
&#xD;
          3. Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of&#xD;
             congenital or hereditary immunodeficiency. HIV is not an exclusion criterion.&#xD;
&#xD;
          4. Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic,&#xD;
             renal or endocrine) disease&#xD;
&#xD;
          5. Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to&#xD;
             formaldehyde and/or 2-phenoxy-ethanol)&#xD;
&#xD;
          6. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections&#xD;
             or blood sampling&#xD;
&#xD;
          7. Treatment with a product which is likely to modify the immune response (e.g. blood&#xD;
             products and immunoglobulins) prior to inclusion or planned during the trial period&#xD;
&#xD;
          8. Participating in another interventional clinical trial&#xD;
&#xD;
          9. Not suitable for inclusion in the opinion of the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>4 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cevaxim</name>
      <address>
        <city>Panama city</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Panama</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 21, 2021</last_update_submitted>
  <last_update_submitted_qc>June 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poliomyelitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04448132
org study id: VIPV-07 E2
nct id: NCT04448132
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The trial is a phase 4, open-label, multicentre clinical trial with healthy subjects who have
      been vaccinated with IPV-Al AJV at 2, 4, 6 and 15 18 months of age in previous trials. Levels
      of antibodies against poliovirus types 1, 2 and 3 after immunisation with IPV Al AJV will be
      measured in the trial subjects at the age of 4 years. An additional IPV-Al AJV dose
      (investigational vaccine) will be administered and the booster response to IPV-Al AJV will be
      investigated one month after administration.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Seroprotection (titer ≥8) against poliovirus types 1, 2 and 3
time frame: One month after administration of an additional dose of IPV-Al AJV
description: Individual serum titers against poliovirus types 1, 2 and three will be measured in collected serum samples
arm group label: IPV-Al AJV
arm group type: Experimental
description: One dose of 0.5 mL of IPV-Al AJV injected intramuscularly perpendicular to the skin in the RIGHT deltoid muscle.
intervention type: Biological
intervention name: IPV-Al
description: adjuvanted reduced dose inactivated polio vaccine
arm group label: IPV-Al AJV
other name: Picovax®
other name: IPV-Al AJV
criteria: 
gender: All
minimum age: 4 Years
maximum age: 4 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Panama
responsible party type: Sponsor
mesh term: Poliomyelitis
sharing ipd: No