<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/NCT03025750</url>
  </required_header>
  <id_info>
    <org_study_id>VIPV-07</org_study_id>
    <nct_id>NCT03025750</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine in 2, 4, 6 Months of Age</brief_title>
  <acronym>VIPV-07</acronym>
  <official_title>Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al SSI, in Comparison to Non-adjuvanted Full Dose IPV SSI, in Infants Vaccinated at 2, 4 and 6 Months of Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Statens Serum Institut</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bill and Melinda Gates Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Larix A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vaxtrials S.A.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AJ Vaccines A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Statens Serum Institut</source>
  <oversight_info>
    <has_dmc>Yes</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 III, non-inferiority, observer-blind, randomised, active controlled,&#xD;
      multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and&#xD;
      IPV SSI (comparator vaccine). The vaccines will be administered at 2, 4 and 6 months of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In addition to the trial vaccines (IPV-Al SSI or IPV SSI), the trial subjects will receive&#xD;
      concomitant childhood vaccinations during the trial period. The trial vaccine (IPV-Al SSI or&#xD;
      IPV SSI) is administered in the RIGHT thigh, whereas the other injectable childhood vaccines&#xD;
      are administered in the opposite (LEFT) thigh.&#xD;
&#xD;
      At Visit 1 (inclusion, screening, blood sample, randomisation and 1st vaccination), written&#xD;
      informed consent is obtained and the subject's eligibility is assessed according to the&#xD;
      pre-specified in-/exclusion criteria. Information on medical history, demographics and&#xD;
      concomitant medication are collected and a physical examination is performed and vital signs&#xD;
      are measured. A prevaccination blood sample is taken for polio antibody determinations and&#xD;
      the subject is randomly allocated into one of the two vaccination groups and vaccinated. A&#xD;
      subset of 200 subjects are randomly chosen to have an extra blood sample taken at Visit 3.&#xD;
      The subject is observed for immediate AEs 30 minutes after all vaccinations. An eDiary,&#xD;
      thermometer and ruler are handed out to the parents for measurements of temperature and&#xD;
      recording of injection site reactions and solicited systemic AEs. These activities are&#xD;
      performed daily, starting on the day of the vaccination and the following 2 days and until&#xD;
      resolved, and for recording of any other AEs as instructed by the trial staff. A contact to&#xD;
      the parents via telephone will be made after the vaccination visit to remind the parents to&#xD;
      fill in the eDiary and to check if they have any questions regarding how use the eDiary.&#xD;
&#xD;
      At Visit 2 (2nd vaccination), 2 months after Visit 1, the eDiary is collected and AEs and&#xD;
      concomitant medications are recorded. Contraindications are reviewed, the 2nd vaccination is&#xD;
      administered, immediate reactions are observed and the eDiary is returned to the partents for&#xD;
      recordings of AEs and concomitant medications. A contact to the parents via telephone will be&#xD;
      made after the vaccination visit to remind the parents to fill in the eDiary and to check if&#xD;
      they have any questions regarding how use the eDiary.&#xD;
&#xD;
      At Visit 3 (3rd vaccination), 2 months after Visit 2, the eDiary is collected and AEs and&#xD;
      concomitant medication are recorded. A blood sample from a subset of the subjects is taken&#xD;
      for polio antibody determinations. Contraindications are reviewed, the 3rd vaccination is&#xD;
      given, immediate reactions are observed and the eDiary is returned to the parents. A contact&#xD;
      to the parents via telephone will be made after the vaccination visit to remind the parents&#xD;
      to fill in the eDiary and to check if they have any questions regarding how use the eDiary.&#xD;
&#xD;
      At Visit 4 (blood sample and trial completion), 1 month after Visit 3, the eDiary is&#xD;
      collected and AEs and concomitant medications are recorded and a blood sample for polio&#xD;
      antibody determination is taken.&#xD;
&#xD;
      A safety follow-up telephone call will be conducted at 12 months of age.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2017</start_date>
  <completion_date type="Actual">November 14, 2017</completion_date>
  <primary_completion_date type="Actual">November 14, 2017</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Seroconversion for poliovirus type 1, 2 and 3 for IPV-Al compared to IPV SSI in infants</measure>
    <time_frame>Change from baseline to one month after 3rd vaccination</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events following vaccinations (key secondary)</measure>
    <time_frame>After primary injections at 2, 4 and 6 months of age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjects with seroprotection against poliovirus types 1, 2 and 3</measure>
    <time_frame>One months after 3rd vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjects with poliovirus types 1, 2 and 3 post-vaccination titres &gt;= 4-fold above estimated titre of maternal antibody</measure>
    <time_frame>One months after 3rd vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric mean titres (GMTs) and median titers for poliovirus types 1, 2 and 3</measure>
    <time_frame>One months after 3rd vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3</measure>
    <time_frame>From baseline and one months after 3rd vaccination</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Subject with seroconversion against poliovirus types 1, 2 and 3</measure>
    <time_frame>Two months after 2nd vaccination</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Subjects with seroprotection against poliovirus types 1, 2 and 3</measure>
    <time_frame>Two months after 2nd vaccination</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Subjects with poliovirus types 1, 2 and 3 post-vaccination titres ≥ 4-fold above estimated titre of maternal antibody</measure>
    <time_frame>Two months after 2nd vaccination</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Geometric mean titres (GMTs) and median titers for poliovirus types 1, 2 and 3</measure>
    <time_frame>Two months after 2nd vaccination</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3</measure>
    <time_frame>From baseline and two months after 2nd vaccination</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Sensitivity analysis: subjects with ≥ 4-fold increases in poliovirus types 1, 2 and 3 titres</measure>
    <time_frame>From baseline and one months after 3rd vaccination</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Sensitivity analysis: sub-groups of subjects with seroprotection (titre ≥ 8) and without seroprotection (titre &lt; 8) at baseline</measure>
    <time_frame>One months after 3rd vaccination</time_frame>
    <description>Subjects with seroconversion against poliovirus types 1, 2 and 3&#xD;
Subjects with seroprotection (titre ≥ 8) against poliovirus types 1, 2 and 3&#xD;
Subjects with poliovirus types 1, 2 and 3 post-vaccination titres ≥ 4-fold above the estimated titre of maternal antibody&#xD;
Geometric mean titres (GMTs) and median titers for poliovirus types 1, 2 and 3&#xD;
Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3 at baseline and one month after 3rd vaccination.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">800</enrollment>
  <condition>Poliomyelitis</condition>
  <arm_group>
    <arm_group_label>IPV-Al SSI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IPV-Al contains the reduced dose of IPV to be administered intramuscularly to the anterolateral of the right thigh. Each subject randomised to this group will receive a total of three primary injections - one at 2 months, 4 months and 6 months of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IPV SSI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IPV SSI contains the full dose of IPV to be administered intramuscularly to the anterolateral of the right thigh. Each subject randomised to this group will receive a total of three primary injections - one at 2 months, 4 months and 6 months of age.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IPV-Al SSI</intervention_name>
    <description>Total of three primary injections of IPV-Al SSI, one at 2, 4 and 6 months of age</description>
    <arm_group_label>IPV-Al SSI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IPV SSI</intervention_name>
    <description>Total of three primary injections of IPV SSI, one at 2, 4 and 6 months of age</description>
    <arm_group_label>IPV SSI</arm_group_label>
    <other_name>IPV Vaccine SSI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants 2 months of age (54-75 days of age) on date of first vaccination&#xD;
&#xD;
          -  Healthy assessed from medical history and physical examination&#xD;
&#xD;
          -  Parent(s)/guardian(s) have been properly informed about the trial and signed informed&#xD;
             consent form&#xD;
&#xD;
          -  Parent(s)/guardian(s)granted access to the infant's trial related medical records&#xD;
&#xD;
          -  Parent(s)/guardian(s)are likely to comply with trial procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vaccinated with any polio vaccine other than the trial vaccines, prior to inclusion or&#xD;
             planned during the trial&#xD;
&#xD;
          -  OPV vaccination or known exposure to poliovirus (wild or vaccine-derived) in household&#xD;
             (living together) within 3 months prior to inclusion or planned during the trial&#xD;
&#xD;
          -  Low birth weight (&lt; 2,500 g)&#xD;
&#xD;
          -  Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of&#xD;
             congenital or hereditary immunodeficiency. HIV infection is not an exclusion criteria&#xD;
&#xD;
          -  Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic,&#xD;
             renal or endocrine) disease&#xD;
&#xD;
          -  Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to&#xD;
             formaldehyde, aluminium or 2-phenoxyethanol)&#xD;
&#xD;
          -  Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections&#xD;
             or blood sampling&#xD;
&#xD;
          -  Treatment with a product which is likely to modify the immune response (e.g. systemic&#xD;
             corticosteroids, blood products and immunoglobulins) prior to inclusion or planned&#xD;
             during the trial period&#xD;
&#xD;
          -  Participating in another clinical trial&#xD;
&#xD;
          -  Not suitable for inclusion in the opinion of the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>54 Days</minimum_age>
    <maximum_age>75 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ingrid Kromann</last_name>
    <role>Study Director</role>
    <affiliation>Statens Serum Institut</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cevaxin</name>
      <address>
        <city>Panama City</city>
        <zip>0816-00383</zip>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Panama</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>November 12, 2018</last_update_submitted>
  <last_update_submitted_qc>November 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2018</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_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/NCT03025750
org study id: VIPV-07
nct id: NCT03025750
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The trial is a phase III, non-inferiority, observer-blind, randomised, active controlled,
      multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and
      IPV SSI (comparator vaccine). The vaccines will be administered at 2, 4 and 6 months of age.
In addition to the trial vaccines (IPV-Al SSI or IPV SSI), the trial subjects will receive
      concomitant childhood vaccinations during the trial period. The trial vaccine (IPV-Al SSI or
      IPV SSI) is administered in the RIGHT thigh, whereas the other injectable childhood vaccines
      are administered in the opposite (LEFT) thigh.

      At Visit 1 (inclusion, screening, blood sample, randomisation and 1st vaccination), written
      informed consent is obtained and the subject's eligibility is assessed according to the
      pre-specified in-/exclusion criteria. Information on medical history, demographics and
      concomitant medication are collected and a physical examination is performed and vital signs
      are measured. A prevaccination blood sample is taken for polio antibody determinations and
      the subject is randomly allocated into one of the two vaccination groups and vaccinated. A
      subset of 200 subjects are randomly chosen to have an extra blood sample taken at Visit 3.
      The subject is observed for immediate AEs 30 minutes after all vaccinations. An eDiary,
      thermometer and ruler are handed out to the parents for measurements of temperature and
      recording of injection site reactions and solicited systemic AEs. These activities are
      performed daily, starting on the day of the vaccination and the following 2 days and until
      resolved, and for recording of any other AEs as instructed by the trial staff. A contact to
      the parents via telephone will be made after the vaccination visit to remind the parents to
      fill in the eDiary and to check if they have any questions regarding how use the eDiary.

      At Visit 2 (2nd vaccination), 2 months after Visit 1, the eDiary is collected and AEs and
      concomitant medications are recorded. Contraindications are reviewed, the 2nd vaccination is
      administered, immediate reactions are observed and the eDiary is returned to the partents for
      recordings of AEs and concomitant medications. A contact to the parents via telephone will be
      made after the vaccination visit to remind the parents to fill in the eDiary and to check if
      they have any questions regarding how use the eDiary.

      At Visit 3 (3rd vaccination), 2 months after Visit 2, the eDiary is collected and AEs and
      concomitant medication are recorded. A blood sample from a subset of the subjects is taken
      for polio antibody determinations. Contraindications are reviewed, the 3rd vaccination is
      given, immediate reactions are observed and the eDiary is returned to the parents. A contact
      to the parents via telephone will be made after the vaccination visit to remind the parents
      to fill in the eDiary and to check if they have any questions regarding how use the eDiary.

      At Visit 4 (blood sample and trial completion), 1 month after Visit 3, the eDiary is
      collected and AEs and concomitant medications are recorded and a blood sample for polio
      antibody determination is taken.

      A safety follow-up telephone call will be conducted at 12 months of age.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Seroconversion for poliovirus type 1, 2 and 3 for IPV-Al compared to IPV SSI in infants
time frame: Change from baseline to one month after 3rd vaccination
measure: Adverse events following vaccinations (key secondary)
time frame: After primary injections at 2, 4 and 6 months of age
measure: Subjects with seroprotection against poliovirus types 1, 2 and 3
time frame: One months after 3rd vaccination
measure: Subjects with poliovirus types 1, 2 and 3 post-vaccination titres >= 4-fold above estimated titre of maternal antibody
time frame: One months after 3rd vaccination
measure: Geometric mean titres (GMTs) and median titers for poliovirus types 1, 2 and 3
time frame: One months after 3rd vaccination
measure: Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3
time frame: From baseline and one months after 3rd vaccination
measure: Subject with seroconversion against poliovirus types 1, 2 and 3
time frame: Two months after 2nd vaccination
measure: Subjects with seroprotection against poliovirus types 1, 2 and 3
time frame: Two months after 2nd vaccination
measure: Subjects with poliovirus types 1, 2 and 3 post-vaccination titres ≥ 4-fold above estimated titre of maternal antibody
time frame: Two months after 2nd vaccination
measure: Geometric mean titres (GMTs) and median titers for poliovirus types 1, 2 and 3
time frame: Two months after 2nd vaccination
measure: Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3
time frame: From baseline and two months after 2nd vaccination
measure: Sensitivity analysis: subjects with ≥ 4-fold increases in poliovirus types 1, 2 and 3 titres
time frame: From baseline and one months after 3rd vaccination
measure: Sensitivity analysis: sub-groups of subjects with seroprotection (titre ≥ 8) and without seroprotection (titre < 8) at baseline
time frame: One months after 3rd vaccination
description: Subjects with seroconversion against poliovirus types 1, 2 and 3
Subjects with seroprotection (titre ≥ 8) against poliovirus types 1, 2 and 3
Subjects with poliovirus types 1, 2 and 3 post-vaccination titres ≥ 4-fold above the estimated titre of maternal antibody
Geometric mean titres (GMTs) and median titers for poliovirus types 1, 2 and 3
Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3 at baseline and one month after 3rd vaccination.
arm group label: IPV-Al SSI
arm group type: Experimental
description: IPV-Al contains the reduced dose of IPV to be administered intramuscularly to the anterolateral of the right thigh. Each subject randomised to this group will receive a total of three primary injections - one at 2 months, 4 months and 6 months of age.
arm group label: IPV SSI
arm group type: Active Comparator
description: IPV SSI contains the full dose of IPV to be administered intramuscularly to the anterolateral of the right thigh. Each subject randomised to this group will receive a total of three primary injections - one at 2 months, 4 months and 6 months of age.
intervention type: Biological
intervention name: IPV-Al SSI
description: Total of three primary injections of IPV-Al SSI, one at 2, 4 and 6 months of age
arm group label: IPV-Al SSI
intervention type: Biological
intervention name: IPV SSI
description: Total of three primary injections of IPV SSI, one at 2, 4 and 6 months of age
arm group label: IPV SSI
other name: IPV Vaccine SSI
criteria: 
gender: All
minimum age: 54 Days
maximum age: 75 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Ingrid Kromann
role: Study Director
affiliation: Statens Serum Institut
facility: 
country: Panama
responsible party type: Sponsor
mesh term: Poliomyelitis
mesh term: Vaccines
sharing ipd: No