<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/NCT03032588</url>
  </required_header>
  <id_info>
    <org_study_id>CR108290</org_study_id>
    <secondary_id>2016-002775-99</secondary_id>
    <secondary_id>GV000051POL1001</secondary_id>
    <nct_id>NCT03032588</nct_id>
  </id_info>
  <brief_title>A First in Human Study to Assess the Safety, Tolerability and Immunogenicity of a Single Dose of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin Strains (sIPV) Given Intramuscularly in Healthy Adults</brief_title>
  <official_title>A First in Human Double-blind, Randomized Study to Assess the Safety, Tolerability and Immunogenicity of a Single Dose of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin Strains (sIPV) Given Intramuscularly in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Vaccines &amp; Prevention B.V.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Vaccines &amp; Prevention B.V.</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 main purpose of this study is to assess the safety and tolerability of a single dose of&#xD;
      JNJ-64152348, inactivated poliovirus vaccine produced from Sabin poliovirus strains on PER.C6&#xD;
      cells (sIPV) in healthy adults, using conventional inactivated poliovirus vaccine produced&#xD;
      from Salk poliovirus strains (cIPV) as reference.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 9, 2017</start_date>
  <completion_date type="Actual">May 18, 2018</completion_date>
  <primary_completion_date type="Actual">May 18, 2018</primary_completion_date>
  <phase>Phase 1</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Solicited Local Adverse Events (AEs)</measure>
    <time_frame>Up to Day 8</time_frame>
    <description>Participants will be requested to record any occurrences of solicited AEs on a daily basis in a diary on the day of dosing and during the 7 days thereafter (up to Day 8). Solicited local AEs include erythema, swelling/induration and pain/tenderness. If erythema or swelling/induration is present, the diameters will be measured using the ruler supplied and the largest diameter recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Solicited Systemic Adverse Events (AEs)</measure>
    <time_frame>Up to Day 8</time_frame>
    <description>Participants will be requested to record any occurrences of solicited AEs on a daily basis in a diary on the day of dosing and during the 7 days thereafter (up to Day 8). Solicited systemic AEs include fatigue, headache, nausea, myalgia and fever.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Unsolicited AEs</measure>
    <time_frame>Up to Week 4</time_frame>
    <description>Unsolicited adverse events will include all adverse events for which the participant is not specifically questioned in the participant diary.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to Week 26</time_frame>
    <description>An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Poliovirus Type- and Strain-specific Neutralizing Antibody (NAb) Responses</measure>
    <time_frame>Up to Week 4</time_frame>
    <description>Polio NAb titers will be determined against the attenuated Sabin strains (Types 1, 2 and 3) as well as against the wild-type Salk strains (Type 1 [Mahoney], Type 2 [MEF-1] and Type 3 [Saukett]), in accordance with the World Health Organization (WHO) recommendations for immunogenicity assessment of inactivated poliovirus vaccine (IPV).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Group 1: sIPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive single intramuscular injection of the trivalent inactivated poliovirus vaccine based on Sabin strains produced on PER.C6 cells (sIPV) on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: cIPV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive single intramuscular injection of the currently used trivalent inactivated poliovirus vaccine IMOVAX POLIO, based on the conventional Salk poliovirus strains produced on Vero cells (cIPV) on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>sIPV</intervention_name>
    <description>Participants will receive single dose (0.5 milliliter [mL]) of sIPV as a suspension for intramuscular injection on Day 1.</description>
    <arm_group_label>Group 1: sIPV</arm_group_label>
    <other_name>JNJ-64152348</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>cIPV</intervention_name>
    <description>Participants will receive single dose (0.5 mL) of cIPV as a suspension for intramuscular injection on Day 1.</description>
    <arm_group_label>Group 2: cIPV</arm_group_label>
    <other_name>IMOVAX POLIO</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Declared healthy by the investigator on the basis of physical examination, medical&#xD;
             history, vital signs and clinical laboratory tests performed at screening. If the&#xD;
             results of the serum chemistry panel or hematology are outside the normal reference&#xD;
             ranges, the participant may be included only if the investigator judges the&#xD;
             abnormalities or deviations from normal to be not clinically significant. This&#xD;
             determination must be recorded in the participant's source documents and initialed by&#xD;
             the investigator&#xD;
&#xD;
          -  Heterosexual male participants must not engage in intercourse with a female partner of&#xD;
             childbearing potential who is not using a highly effective contraceptive method&#xD;
&#xD;
          -  All female participants of childbearing potential must have a negative urine&#xD;
             beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and&#xD;
             immediately prior to study vaccine administration&#xD;
&#xD;
          -  Willing and able to adhere to the prohibitions and restrictions specified in this&#xD;
             protocol&#xD;
&#xD;
          -  Agrees not to donate blood until the Week 4 visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant neuro-psychiatric, cardiovascular, pulmonary, liver or renal&#xD;
             insufficiency (estimated creatinine clearance below 60 milliliter per minute (mL/min)&#xD;
             using the Cockcroft-Gault Equation); metabolic, gastrointestinal, urologic, or&#xD;
             endocrine disease that is - in the opinion of the investigator - uncontrolled&#xD;
&#xD;
          -  Any history of malignancy (exceptions are squamous and basal cell carcinomas of the&#xD;
             skin and carcinoma in situ of the cervix, or malignancy, which is considered cured&#xD;
             with minimal risk of recurrence)&#xD;
&#xD;
          -  Previous severe allergic reaction after vaccination with polio vaccine&#xD;
&#xD;
          -  Known allergies, hypersensitivity, or intolerance to one of the excipients of&#xD;
             JNJ-64152348, inactivated poliovirus vaccine produced from Sabin poliovirus strains on&#xD;
             PER.C6 cells (sIPV) or conventional inactivated poliovirus vaccine produced from Salk&#xD;
             poliovirus strains (cIPV)&#xD;
&#xD;
          -  Received any polio vaccine within 6 months before study inclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Vaccines &amp; Prevention B.V. Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Vaccines &amp; Prevention B.V.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Vaccinology (CEVAC)</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>July 4, 2019</last_update_submitted>
  <last_update_submitted_qc>July 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03032588
org study id: CR108290
secondary id: 2016-002775-99
secondary id: GV000051POL1001
nct id: NCT03032588
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to assess the safety and tolerability of a single dose of
      JNJ-64152348, inactivated poliovirus vaccine produced from Sabin poliovirus strains on PER.C6
      cells (sIPV) in healthy adults, using conventional inactivated poliovirus vaccine produced
      from Salk poliovirus strains (cIPV) as reference.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants With Solicited Local Adverse Events (AEs)
time frame: Up to Day 8
description: Participants will be requested to record any occurrences of solicited AEs on a daily basis in a diary on the day of dosing and during the 7 days thereafter (up to Day 8). Solicited local AEs include erythema, swelling/induration and pain/tenderness. If erythema or swelling/induration is present, the diameters will be measured using the ruler supplied and the largest diameter recorded.
measure: Number of Participants With Solicited Systemic Adverse Events (AEs)
time frame: Up to Day 8
description: Participants will be requested to record any occurrences of solicited AEs on a daily basis in a diary on the day of dosing and during the 7 days thereafter (up to Day 8). Solicited systemic AEs include fatigue, headache, nausea, myalgia and fever.
measure: Number of Participants With Unsolicited AEs
time frame: Up to Week 4
description: Unsolicited adverse events will include all adverse events for which the participant is not specifically questioned in the participant diary.
measure: Number of Participants With Serious Adverse Events (SAEs)
time frame: Up to Week 26
description: An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
measure: Poliovirus Type- and Strain-specific Neutralizing Antibody (NAb) Responses
time frame: Up to Week 4
description: Polio NAb titers will be determined against the attenuated Sabin strains (Types 1, 2 and 3) as well as against the wild-type Salk strains (Type 1 [Mahoney], Type 2 [MEF-1] and Type 3 [Saukett]), in accordance with the World Health Organization (WHO) recommendations for immunogenicity assessment of inactivated poliovirus vaccine (IPV).
arm group label: Group 1: sIPV
arm group type: Experimental
description: Participants will receive single intramuscular injection of the trivalent inactivated poliovirus vaccine based on Sabin strains produced on PER.C6 cells (sIPV) on Day 1.
arm group label: Group 2: cIPV
arm group type: Active Comparator
description: Participants will receive single intramuscular injection of the currently used trivalent inactivated poliovirus vaccine IMOVAX POLIO, based on the conventional Salk poliovirus strains produced on Vero cells (cIPV) on Day 1.
intervention type: Biological
intervention name: sIPV
description: Participants will receive single dose (0.5 milliliter [mL]) of sIPV as a suspension for intramuscular injection on Day 1.
arm group label: Group 1: sIPV
other name: JNJ-64152348
intervention type: Biological
intervention name: cIPV
description: Participants will receive single dose (0.5 mL) of cIPV as a suspension for intramuscular injection on Day 1.
arm group label: Group 2: cIPV
other name: IMOVAX POLIO
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: Study Director
affiliation: Janssen Vaccines & Prevention B.V.
facility: 
country: Belgium
responsible party type: Sponsor