<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/NCT03016949</url>
  </required_header>
  <id_info>
    <org_study_id>IPV-003-ABMG</org_study_id>
    <nct_id>NCT03016949</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Immunogenicity of Various Schedules of Inactivated Polio Vaccine</brief_title>
  <official_title>A Phase 3, Open-label, Randomized Trial to Evaluate Humoral Immunogenicity of Various Schedules of Intramuscular Full Dose and Intradermal Fractional Dose of Inactivated Polio Vaccine in Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fidec Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bill and Melinda Gates Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fidec Corporation</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 study will evaluate the humoral immunogenicity in various schedule combinations of full&#xD;
      dose inactivated polio vaccines (IPV) via intramuscular administration (IM) and of the&#xD;
      fractional dose of inactivated poliovaccine (f-IPV) via intradermal administration (ID).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted in a setting where only IPV is being used for polio prevention in&#xD;
      infant immunization schedules.&#xD;
&#xD;
      The study population will include infants from Uruguay, a pioneer country in immunization&#xD;
      programs in Latin America, where tOPV(trivalent oral polio vaccine) was used until 2012,&#xD;
      after which the program changed to an all-IPV schedule without transition.&#xD;
&#xD;
      The primary IPV immunization schedule in the country is as stand-alone vaccine at 2, 4 and 6&#xD;
      months of age, with a booster dose at 15 months. This setting allows the evaluation of IPV&#xD;
      immunogenicity in a scenario where the circulation of any poliovirus is highly unlikely.&#xD;
&#xD;
      Infants will receive two or three doses of full dose IPV IM or fractional dose f-IPV ID, in&#xD;
      various schedule combinations (6 and 14 weeks; 10 and 14 weeks; 14 and 36 weeks; 6, 14 and 36&#xD;
      weeks; 10, 14 and 36 weeks). Immunological and safety assessments will be made after one&#xD;
      dose, two doses and three doses.&#xD;
&#xD;
      The study will be conducted in Montevideo, Uruguay and a total of 1493 infants will be&#xD;
      randomized into 6 groups. Other vaccines comprise DTPw-HB-Hib (pentavalent combined&#xD;
      diphtheria-tetanus-whole cell pertussis-hepatitis B-Hib vaccine), Pneumococcal conjugate&#xD;
      vaccine, Rotavirus and will be administered concomitantly.&#xD;
&#xD;
      Optimum immunogenicity expected from the dose/s of IPV in the post-eradication era will have&#xD;
      to be balanced with the cost and supply constraints of IPV. This study will be critical to&#xD;
      determine how many doses of IPV and which schedule will be recommended for the&#xD;
      post-eradication era after the cessation of OPV (oral polio vaccine) usage globally.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Regulatory timelines for approval expired&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2017</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2018</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Seroconversion</measure>
    <time_frame>To be assessed four weeks after the second vaccination for all groups receiving 2 doses of IPV and four weeks after the second vaccination for all groups receiving 2 doses of f-IPV.</time_frame>
    <description>Seroconversion will be defined as a change from seronegative to seropositive (antibody titers of ≥1:8) and in infants seropositive at baseline (assumed to be from maternally-derived antibody titers), as a ≥4-fold rise in antibody titers post-vaccination, computed by assuming an exponential decay model with a half-life of 24 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Seroconversion</measure>
    <time_frame>To be assessed four weeks after the second or third vaccination, respectively, for the groups receiving IPV and four weeks after the second or third vaccination, respectively, for the groups receiving f-IPV.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median titers</measure>
    <time_frame>To be assessed four weeks after the second or third vaccination, respectively, for the groups receiving IPV and four weeks after the second or third vaccination, respectively, for the groups receiving f-IPV.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SAEs (Serious Adverse Events)</measure>
    <time_frame>To be assessed throughout the complete study period, approx. 18 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IMEs (Important Medical Events)</measure>
    <time_frame>To be assessed throughout the complete study period, approx. 18 months.</time_frame>
    <description>These are medically significant events that do not meet any of the SAE criteria, but require medical or surgical consultation or intervention to prevent this event from becoming a SAE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe local reactions</measure>
    <time_frame>To be assessed throughout the complete study period, approx. 18 months.</time_frame>
    <description>Severe local reactions can include severe pain, inflammation, induration and edema in the injection area.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Poliomyelitis</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 doses IPV IM at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 18, 36 &amp; 40 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 doses f-IPV ID at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 18, 36 &amp; 40 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 doses IPV IM at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 doses f-IPV ID at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 doses IPV IM at 6, 14 &amp; 36 weeks of age incl. blood sampling at 6, 18, 36 &amp; 40 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group F</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 doses f-IPV ID at 6, 14 &amp; 36 weeks of age incl. blood sampling at 6, 18, 36 &amp; 40 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IPV</intervention_name>
    <description>Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group E</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>f-IPV</intervention_name>
    <description>Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_label>Group F</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants of 6 weeks of age (-7 to + 7 days) on date of first vaccination&#xD;
&#xD;
          -  Healthy, as assessed from medical history and physical examination by a study&#xD;
             physician&#xD;
&#xD;
          -  Written informed consent obtained from parents or legal representatives that they have&#xD;
             been properly informed about the study and are able to comply with planned study&#xD;
             procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vaccinated with any poliovirus vaccine prior to inclusion&#xD;
&#xD;
          -  A household contact with OPV vaccination history in the past 4 weeks&#xD;
&#xD;
          -  HIV infection or pharmacologic immunosuppression.&#xD;
&#xD;
          -  Known allergy to any component of the study vaccines (phenoxyethanol, formaldehyde)&#xD;
&#xD;
          -  Uncontrolled coagulopathy or blood disorder contraindicating intramuscular and&#xD;
             intradermal injections.&#xD;
&#xD;
          -  Acute severe febrile illness on day of vaccination deemed by the Investigator to be a&#xD;
             contraindication for vaccination.&#xD;
&#xD;
          -  Not suitable for inclusion or is unlikely to comply with the protocol in the opinion&#xD;
             of the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Weeks</minimum_age>
    <maximum_age>7 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stella Gutierrez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CASMU Polyclinic 8 de Octubre 3310 Montevideo, Uruguay</affiliation>
  </overall_official>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>June 26, 2017</last_update_submitted>
  <last_update_submitted_qc>June 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2017</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>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/NCT03016949
org study id: IPV-003-ABMG
nct id: NCT03016949
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will evaluate the humoral immunogenicity in various schedule combinations of full
      dose inactivated polio vaccines (IPV) via intramuscular administration (IM) and of the
      fractional dose of inactivated poliovaccine (f-IPV) via intradermal administration (ID).
The study will be conducted in a setting where only IPV is being used for polio prevention in
      infant immunization schedules.

      The study population will include infants from Uruguay, a pioneer country in immunization
      programs in Latin America, where tOPV(trivalent oral polio vaccine) was used until 2012,
      after which the program changed to an all-IPV schedule without transition.

      The primary IPV immunization schedule in the country is as stand-alone vaccine at 2, 4 and 6
      months of age, with a booster dose at 15 months. This setting allows the evaluation of IPV
      immunogenicity in a scenario where the circulation of any poliovirus is highly unlikely.

      Infants will receive two or three doses of full dose IPV IM or fractional dose f-IPV ID, in
      various schedule combinations (6 and 14 weeks; 10 and 14 weeks; 14 and 36 weeks; 6, 14 and 36
      weeks; 10, 14 and 36 weeks). Immunological and safety assessments will be made after one
      dose, two doses and three doses.

      The study will be conducted in Montevideo, Uruguay and a total of 1493 infants will be
      randomized into 6 groups. Other vaccines comprise DTPw-HB-Hib (pentavalent combined
      diphtheria-tetanus-whole cell pertussis-hepatitis B-Hib vaccine), Pneumococcal conjugate
      vaccine, Rotavirus and will be administered concomitantly.

      Optimum immunogenicity expected from the dose/s of IPV in the post-eradication era will have
      to be balanced with the cost and supply constraints of IPV. This study will be critical to
      determine how many doses of IPV and which schedule will be recommended for the
      post-eradication era after the cessation of OPV (oral polio vaccine) usage globally.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Seroconversion
time frame: To be assessed four weeks after the second vaccination for all groups receiving 2 doses of IPV and four weeks after the second vaccination for all groups receiving 2 doses of f-IPV.
description: Seroconversion will be defined as a change from seronegative to seropositive (antibody titers of ≥1:8) and in infants seropositive at baseline (assumed to be from maternally-derived antibody titers), as a ≥4-fold rise in antibody titers post-vaccination, computed by assuming an exponential decay model with a half-life of 24 days.
measure: Seroconversion
time frame: To be assessed four weeks after the second or third vaccination, respectively, for the groups receiving IPV and four weeks after the second or third vaccination, respectively, for the groups receiving f-IPV.
measure: Median titers
time frame: To be assessed four weeks after the second or third vaccination, respectively, for the groups receiving IPV and four weeks after the second or third vaccination, respectively, for the groups receiving f-IPV.
measure: SAEs (Serious Adverse Events)
time frame: To be assessed throughout the complete study period, approx. 18 months.
measure: IMEs (Important Medical Events)
time frame: To be assessed throughout the complete study period, approx. 18 months.
description: These are medically significant events that do not meet any of the SAE criteria, but require medical or surgical consultation or intervention to prevent this event from becoming a SAE.
measure: Severe local reactions
time frame: To be assessed throughout the complete study period, approx. 18 months.
description: Severe local reactions can include severe pain, inflammation, induration and edema in the injection area.
arm group label: Group A
arm group type: Experimental
description: 3 doses IPV IM at 10, 14 & 36 weeks of age incl. blood sampling at 10, 18, 36 & 40 weeks.
arm group label: Group B
arm group type: Experimental
description: 3 doses f-IPV ID at 10, 14 & 36 weeks of age incl. blood sampling at 10, 18, 36 & 40 weeks.
arm group label: Group C
arm group type: Experimental
description: 2 doses IPV IM at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.
arm group label: Group D
arm group type: Experimental
description: 2 doses f-IPV ID at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.
arm group label: Group E
arm group type: Experimental
description: 3 doses IPV IM at 6, 14 & 36 weeks of age incl. blood sampling at 6, 18, 36 & 40 weeks.
arm group label: Group F
arm group type: Experimental
description: 3 doses f-IPV ID at 6, 14 & 36 weeks of age incl. blood sampling at 6, 18, 36 & 40 weeks.
intervention type: Biological
intervention name: IPV
description: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
arm group label: Group A
arm group label: Group C
arm group label: Group E
intervention type: Biological
intervention name: f-IPV
description: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
arm group label: Group B
arm group label: Group D
arm group label: Group F
criteria: 
gender: All
minimum age: 5 Weeks
maximum age: 7 Weeks
healthy volunteers: Accepts Healthy Volunteers
last name: Stella Gutierrez, MD
role: Principal Investigator
affiliation: CASMU Polyclinic 8 de Octubre 3310 Montevideo, Uruguay
responsible party type: Sponsor
mesh term: Poliomyelitis
sharing ipd: Undecided