<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/NCT03819049</url>
  </required_header>
  <id_info>
    <org_study_id>CR108580</org_study_id>
    <secondary_id>VAC52416BAC1001</secondary_id>
    <secondary_id>2020-000657-27</secondary_id>
    <nct_id>NCT03819049</nct_id>
  </id_info>
  <brief_title>A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health</brief_title>
  <official_title>A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of 3&#xD;
      different doses of ExPEC10V and to select the optimal dose for further clinical development&#xD;
      (Cohort 1). Cohort 2 is aimed to expand the dataset supporting the short- and long-term&#xD;
      safety and immunogenicity of the optimal dose of ExPEC10V, selected from the primary analysis&#xD;
      results of Cohort 1. Cohort 2 will include participants in stable health with a history of&#xD;
      urinary tract infection (UTI) in the past 5 years and will be included in the study to&#xD;
      support the plan for late stage development of ExPEC vaccine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ExPEC10V (JNJ-69968054) is a 10-valent vaccine candidate in development for prevention of&#xD;
      invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease (IED) in adults 60 years&#xD;
      of age and older. ExPEC10V consists of O-antigen polysaccharides (PSs) of the ExPEC serotypes&#xD;
      O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 separately bioconjugate to the carrier&#xD;
      protein, a genetically detoxified form of exotoxin A (EPA) derived from Pseudomonas&#xD;
      aeruginosa. Since, mechanism of action of conjugate vaccines in prevention of invasive&#xD;
      disease is not expected to be affected by antibiotic resistance mechanisms, ExPEC10V vaccine&#xD;
      may provide protection against IED caused by drug resistant and susceptible ExPEC serotypes.&#xD;
      The study consists of two cohorts. Cohort 1 is comprised of three periods: a screening period&#xD;
      (28 days), an observer-blind follow-up period (181 days) with vaccination on Day 1, and an&#xD;
      open-label long term follow up (LTFU) period (from Day 182 until 5 years [Day 1826]&#xD;
      post-vaccination). Cohort 2 is also comprised of three periods: a screening period (28 days),&#xD;
      a double-blind follow-up period (181 days) with vaccination on Day 1, and a double-blind LTFU&#xD;
      period (from Day 182 until 1 years [Day 366] post-vaccination). The end of Cohort 1 is&#xD;
      considered as the Year 5 visit (Day 1826) for the last participant. The end of Cohort 2 is&#xD;
      considered as the Year 1 visit (Day 366) for the last participant. Key immunogenicity&#xD;
      assessments will include the assessment of ExPEC10V and ExPEC4V serotype-specific total&#xD;
      immunoglobulin G antibody levels elicited by the vaccine and ExPEC10V and ExPEC4V&#xD;
      serotype-specific functional antibodies. Key safety assessments include solicited local and&#xD;
      systemic AEs, unsolicited AEs, SAEs, physical examinations, vital sign measurements, and, for&#xD;
      Cohort 1 only, clinical laboratory tests. The total duration of the study is up to 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 6, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2024</completion_date>
  <primary_completion_date type="Actual">June 8, 2021</primary_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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cohort 1 and Cohort 2: Number of Participants with Solicited Local and Systemic Adverse Events (AEs) Collected for 14 days post-Vaccination</measure>
    <time_frame>From Day 1 to Day 15</time_frame>
    <description>Number of participants with solicited local and systemic AEs will be reported. Solicited local AEs (pain/tenderness, erythema, and swelling at the injection site) and solicited systemic AEs (oral body temperature, headache, fatigue, nausea, and myalgia) will be noted in the participant diary for 14 days post-vaccination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cohort 1 and Cohort 2: Number of Participants with Unsolicited Adverse Events From the Administration of Study Vaccine until 29 Days post-Vaccination</measure>
    <time_frame>From Day 1 to Day 30</time_frame>
    <description>Number of participants with unsolicited AEs will be reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Unsolicited adverse events are all adverse events for which the participant is not specifically questioned in the participant ediary.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cohort 1 and Cohort 2: Number of Participants with Serious Adverse Events (SAE's) from the Administration of the Study Vaccine until Day 181</measure>
    <time_frame>Up to Day 181</time_frame>
    <description>Number of participants with SAEs will be reported. 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, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay on Day 15</measure>
    <time_frame>On Day 15</time_frame>
    <description>Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex Opsonophagocytic Assay (MOPA) on Day 15</measure>
    <time_frame>On Day 15</time_frame>
    <description>Antibody titers for ExPEC10V will be determined by MOPA.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cohort 2: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay on Day 30</measure>
    <time_frame>On Day 30</time_frame>
    <description>Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cohort 2: Antibody Titers for ExPEC10V as Determined by MOPA on Day 30</measure>
    <time_frame>On Day 30</time_frame>
    <description>Antibody titers for ExPEC10V will be determined by MOPA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay and MOPA to find Correlation Between Multiplex ECL-based Immunoassay and MOPA</measure>
    <time_frame>Day 15</time_frame>
    <description>Antibody titers for ExPEC10V as determined by multiplex ECL-based immunoassay and MOPA to find correlation between multiplex ECL-based immunoassay and MOPA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay on Days 30, 181, 366, 731, 1096, 1461, and 1826</measure>
    <time_frame>On Days 30, 181, 366, 731, 1096, 1461, and 1826</time_frame>
    <description>Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1: Antibody Titers for ExPEC10V as Determined by MOPA on Days 30, 181, 366, 731, 1096, 1461, and 1826</measure>
    <time_frame>On Days 30, 181, 366, 731, 1096, 1461, and 1826</time_frame>
    <description>Antibody titers for ExPEC10V will be determined by MOPA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 2: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay and MOPA to find Correlation Between Multiplex ECL-based Immunoassay and MOPA</measure>
    <time_frame>Day 30</time_frame>
    <description>Antibody titers for ExPEC10V as determined by multiplex ECL-based immunoassay and MOPA to find correlation between multiplex ECL-based immunoassay and MOPA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 2: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay on Days 15, 181, and 366</measure>
    <time_frame>On Days 15, 181, and 366</time_frame>
    <description>Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 2: Antibody Titers for ExPEC10V as Determined by MOPA on Days 181, and 366</measure>
    <time_frame>On Days 181, and 366</time_frame>
    <description>Antibody titers for ExPEC10V will be determined by MOPA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1 and Cohort 2: Number of Participants with Serious Adverse Events Related to the Study Intervention or Study Procedures From Day 182 Until the end of the Study</measure>
    <time_frame>Cohort 1: Day 1826 and Cohort 2: Day 366</time_frame>
    <description>Number of participants with SAEs related to the study intervention or study procedures will be reported. 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, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">836</enrollment>
  <condition>Extraintestinal Pathogenic Escherichia Coli Prevention</condition>
  <arm_group>
    <arm_group_label>Cohort 1: ExPEC10V (Low Dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized to receive a single intramuscular (IM) injection of low dose ExPEC10V on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1: ExPEC10V (Medium dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized to receive a single IM injection of medium dose ExPEC10V on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1: ExPEC10V (High dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized to receive a single IM injection of high dose ExPEC10V on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1: ExPEC4V</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized to receive a single IM injection of ExPEC4V on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1: Prevnar 13</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized to receive a single IM injection of Prevnar 13 on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: ExPEC10V</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized to receive a single IM injection of selected dose of ExPEC10V on Day 1. The ExPEC10V dose used in Cohort 2 will be based on the primary analysis (Day 30) results of Cohort 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be randomized to receive a single IM injection of matching placebo on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ExPEC10V</intervention_name>
    <description>Participants will receive a single IM injection of ExPEC10V (1 of 3 doses [low or medium or high]) in Cohort 1 and ExPEC10V selected dose (based on the primary analysis results of Cohort 1) in Cohort 2 on Day 1.</description>
    <arm_group_label>Cohort 1: ExPEC10V (High dose)</arm_group_label>
    <arm_group_label>Cohort 1: ExPEC10V (Low Dose)</arm_group_label>
    <arm_group_label>Cohort 1: ExPEC10V (Medium dose)</arm_group_label>
    <arm_group_label>Cohort 2: ExPEC10V</arm_group_label>
    <other_name>VAC52416</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ExPEC4V</intervention_name>
    <description>Participants will receive a single IM injection of ExPEC4V on Day 1.</description>
    <arm_group_label>Cohort 1: ExPEC4V</arm_group_label>
    <other_name>JNJ-63871860</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Prevnar 13</intervention_name>
    <description>Participants will receive a single IM injection of Prevnar 13 on Day 1.</description>
    <arm_group_label>Cohort 1: Prevnar 13</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive single IM injection of matching placebo on Day 1.</description>
    <arm_group_label>Cohort 2: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have a body mass index (BMI) of greater than (&gt;) 18.5 or less than 40 kilogram&#xD;
             per meter square (kg/m^2)&#xD;
&#xD;
          -  Before randomization, a woman must be: postmenopausal - A postmenopausal state is&#xD;
             defined as no menses for 12 months without an alternative medical cause; or not&#xD;
             intending to conceive by any methods&#xD;
&#xD;
          -  Must be healthy or medically stable&#xD;
&#xD;
          -  Must sign an informed consent form (ICF) indicating that he or she understands the&#xD;
             purpose of, and procedures required for, the study and is willing to participate in&#xD;
             the study&#xD;
&#xD;
          -  Willing and able to adhere to the lifestyle restrictions specified in this protocol&#xD;
&#xD;
          -  Agrees not to donate blood until 12 weeks after receiving the study vaccine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute illness (this does not include minor illnesses such as diarrhea or mild upper&#xD;
             respiratory tract infection) or temperature greater than equal to &gt;=38.0 degree&#xD;
             Celsius (100.4 degree Fahrenheit) within 24 hours prior to the administration of study&#xD;
             vaccine, or, applicable for Cohort 2 only, an ongoing or suspected symptomatic urinary&#xD;
             tract infection (UTI); enrollment at a later date is permitted (provided the screening&#xD;
             window of 28 days is respected)&#xD;
&#xD;
          -  History of malignancy within 5 years before screening (exceptions are squamous and&#xD;
             basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy,&#xD;
             which is considered cured with minimal risk of recurrence)&#xD;
&#xD;
          -  Known allergies, hypersensitivity, or intolerance to ExPEC10V or its excipients&#xD;
&#xD;
          -  Applicable for Cohort 1 only: known allergy or history of anaphylaxis or other serious&#xD;
             adverse reactions to vaccines or vaccine products (including any of the constituents&#xD;
             of the active control vaccines)&#xD;
&#xD;
          -  Contraindication to intramuscular (IM) injections and blood draws example, bleeding&#xD;
             disorders&#xD;
&#xD;
          -  Abnormal function of the immune system&#xD;
&#xD;
          -  Has had major psychiatric illness and/or drug substance or alcohol abuse in the past&#xD;
             12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Optimal Research</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimal Research</name>
      <address>
        <city>Melbourne</city>
        <state>Florida</state>
        <zip>32934</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qps-Mra, Llc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimal Research</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johnson County Clin-Trials</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Richfield</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Manhattan</city>
        <state>New York</state>
        <zip>10017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester Clinical Research, Inc</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44311</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Carolina Research Center</name>
      <address>
        <city>North Charleston</city>
        <state>South Carolina</state>
        <zip>29405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anima</name>
      <address>
        <city>Alken</city>
        <zip>3570</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ATC Pharma</name>
      <address>
        <city>Luik</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Pharmacology Unit</name>
      <address>
        <city>Merksem</city>
        <zip>2170</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP - Hopital Bichat - Claude Bernard</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Lyon Sud</name>
      <address>
        <city>Pierre Benite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Rennes - Hopital Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Tours Hôpital Bretonneau</name>
      <address>
        <city>Tours</city>
        <zip>37000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EB Flevo Research</name>
      <address>
        <city>Almere</city>
        <zip>1311 RL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PRA Health Sciences</name>
      <address>
        <city>Groningen</city>
        <zip>NZ 9728</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>8003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Reina Sofia</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. de La Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. Marques de Valdecilla</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <disposition_first_submitted>June 3, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>June 3, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 7, 2022</disposition_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2023</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>Escherichia coli Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heptavalent Pneumococcal Conjugate Vaccine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data sharing policy of the Janssen Pharmaceutical Companies of Johnson &amp; Johnson is available at www.janssen.com/clinical-trials\transparency.&#xD;
As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu</ipd_description>
    <ipd_url>https://www.janssen.com/clinical-trials/transparency</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03819049
org study id: CR108580
secondary id: VAC52416BAC1001
secondary id: 2020-000657-27
nct id: NCT03819049
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of 3
      different doses of ExPEC10V and to select the optimal dose for further clinical development
      (Cohort 1). Cohort 2 is aimed to expand the dataset supporting the short- and long-term
      safety and immunogenicity of the optimal dose of ExPEC10V, selected from the primary analysis
      results of Cohort 1. Cohort 2 will include participants in stable health with a history of
      urinary tract infection (UTI) in the past 5 years and will be included in the study to
      support the plan for late stage development of ExPEC vaccine.
ExPEC10V (JNJ-69968054) is a 10-valent vaccine candidate in development for prevention of
      invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease (IED) in adults 60 years
      of age and older. ExPEC10V consists of O-antigen polysaccharides (PSs) of the ExPEC serotypes
      O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 separately bioconjugate to the carrier
      protein, a genetically detoxified form of exotoxin A (EPA) derived from Pseudomonas
      aeruginosa. Since, mechanism of action of conjugate vaccines in prevention of invasive
      disease is not expected to be affected by antibiotic resistance mechanisms, ExPEC10V vaccine
      may provide protection against IED caused by drug resistant and susceptible ExPEC serotypes.
      The study consists of two cohorts. Cohort 1 is comprised of three periods: a screening period
      (28 days), an observer-blind follow-up period (181 days) with vaccination on Day 1, and an
      open-label long term follow up (LTFU) period (from Day 182 until 5 years [Day 1826]
      post-vaccination). Cohort 2 is also comprised of three periods: a screening period (28 days),
      a double-blind follow-up period (181 days) with vaccination on Day 1, and a double-blind LTFU
      period (from Day 182 until 1 years [Day 366] post-vaccination). The end of Cohort 1 is
      considered as the Year 5 visit (Day 1826) for the last participant. The end of Cohort 2 is
      considered as the Year 1 visit (Day 366) for the last participant. Key immunogenicity
      assessments will include the assessment of ExPEC10V and ExPEC4V serotype-specific total
      immunoglobulin G antibody levels elicited by the vaccine and ExPEC10V and ExPEC4V
      serotype-specific functional antibodies. Key safety assessments include solicited local and
      systemic AEs, unsolicited AEs, SAEs, physical examinations, vital sign measurements, and, for
      Cohort 1 only, clinical laboratory tests. The total duration of the study is up to 5 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Cohort 1 and Cohort 2: Number of Participants with Solicited Local and Systemic Adverse Events (AEs) Collected for 14 days post-Vaccination
time frame: From Day 1 to Day 15
description: Number of participants with solicited local and systemic AEs will be reported. Solicited local AEs (pain/tenderness, erythema, and swelling at the injection site) and solicited systemic AEs (oral body temperature, headache, fatigue, nausea, and myalgia) will be noted in the participant diary for 14 days post-vaccination.
measure: Cohort 1 and Cohort 2: Number of Participants with Unsolicited Adverse Events From the Administration of Study Vaccine until 29 Days post-Vaccination
time frame: From Day 1 to Day 30
description: Number of participants with unsolicited AEs will be reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Unsolicited adverse events are all adverse events for which the participant is not specifically questioned in the participant ediary.
measure: Cohort 1 and Cohort 2: Number of Participants with Serious Adverse Events (SAE's) from the Administration of the Study Vaccine until Day 181
time frame: Up to Day 181
description: Number of participants with SAEs will be reported. 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, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
measure: Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay on Day 15
time frame: On Day 15
description: Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.
measure: Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex Opsonophagocytic Assay (MOPA) on Day 15
time frame: On Day 15
description: Antibody titers for ExPEC10V will be determined by MOPA.
measure: Cohort 2: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay on Day 30
time frame: On Day 30
description: Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.
measure: Cohort 2: Antibody Titers for ExPEC10V as Determined by MOPA on Day 30
time frame: On Day 30
description: Antibody titers for ExPEC10V will be determined by MOPA.
measure: Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay and MOPA to find Correlation Between Multiplex ECL-based Immunoassay and MOPA
time frame: Day 15
description: Antibody titers for ExPEC10V as determined by multiplex ECL-based immunoassay and MOPA to find correlation between multiplex ECL-based immunoassay and MOPA
measure: Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay on Days 30, 181, 366, 731, 1096, 1461, and 1826
time frame: On Days 30, 181, 366, 731, 1096, 1461, and 1826
description: Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.
measure: Cohort 1: Antibody Titers for ExPEC10V as Determined by MOPA on Days 30, 181, 366, 731, 1096, 1461, and 1826
time frame: On Days 30, 181, 366, 731, 1096, 1461, and 1826
description: Antibody titers for ExPEC10V will be determined by MOPA.
measure: Cohort 2: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay and MOPA to find Correlation Between Multiplex ECL-based Immunoassay and MOPA
time frame: Day 30
description: Antibody titers for ExPEC10V as determined by multiplex ECL-based immunoassay and MOPA to find correlation between multiplex ECL-based immunoassay and MOPA
measure: Cohort 2: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay on Days 15, 181, and 366
time frame: On Days 15, 181, and 366
description: Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.
measure: Cohort 2: Antibody Titers for ExPEC10V as Determined by MOPA on Days 181, and 366
time frame: On Days 181, and 366
description: Antibody titers for ExPEC10V will be determined by MOPA.
measure: Cohort 1 and Cohort 2: Number of Participants with Serious Adverse Events Related to the Study Intervention or Study Procedures From Day 182 Until the end of the Study
time frame: Cohort 1: Day 1826 and Cohort 2: Day 366
description: Number of participants with SAEs related to the study intervention or study procedures will be reported. 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, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
arm group label: Cohort 1: ExPEC10V (Low Dose)
arm group type: Experimental
description: Participants will be randomized to receive a single intramuscular (IM) injection of low dose ExPEC10V on Day 1.
arm group label: Cohort 1: ExPEC10V (Medium dose)
arm group type: Experimental
description: Participants will be randomized to receive a single IM injection of medium dose ExPEC10V on Day 1.
arm group label: Cohort 1: ExPEC10V (High dose)
arm group type: Experimental
description: Participants will be randomized to receive a single IM injection of high dose ExPEC10V on Day 1.
arm group label: Cohort 1: ExPEC4V
arm group type: Experimental
description: Participants will be randomized to receive a single IM injection of ExPEC4V on Day 1.
arm group label: Cohort 1: Prevnar 13
arm group type: Experimental
description: Participants will be randomized to receive a single IM injection of Prevnar 13 on Day 1.
arm group label: Cohort 2: ExPEC10V
arm group type: Experimental
description: Participants will be randomized to receive a single IM injection of selected dose of ExPEC10V on Day 1. The ExPEC10V dose used in Cohort 2 will be based on the primary analysis (Day 30) results of Cohort 1.
arm group label: Cohort 2: Placebo
arm group type: Placebo Comparator
description: Participants will be randomized to receive a single IM injection of matching placebo on Day 1.
intervention type: Biological
intervention name: ExPEC10V
description: Participants will receive a single IM injection of ExPEC10V (1 of 3 doses [low or medium or high]) in Cohort 1 and ExPEC10V selected dose (based on the primary analysis results of Cohort 1) in Cohort 2 on Day 1.
arm group label: Cohort 1: ExPEC10V (High dose)
arm group label: Cohort 1: ExPEC10V (Low Dose)
arm group label: Cohort 1: ExPEC10V (Medium dose)
arm group label: Cohort 2: ExPEC10V
other name: VAC52416
intervention type: Biological
intervention name: ExPEC4V
description: Participants will receive a single IM injection of ExPEC4V on Day 1.
arm group label: Cohort 1: ExPEC4V
other name: JNJ-63871860
intervention type: Biological
intervention name: Prevnar 13
description: Participants will receive a single IM injection of Prevnar 13 on Day 1.
arm group label: Cohort 1: Prevnar 13
intervention type: Biological
intervention name: Placebo
description: Participants will receive single IM injection of matching placebo on Day 1.
arm group label: Cohort 2: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
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country: Belgium
country: France
country: Netherlands
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Escherichia coli Infections
mesh term: Heptavalent Pneumococcal Conjugate Vaccine
sharing ipd: Yes
ipd description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency.
As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
ipd url: https://www.janssen.com/clinical-trials/transparency