<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/NCT04453202</url>
  </required_header>
  <id_info>
    <org_study_id>CR108835</org_study_id>
    <secondary_id>VAC18193RSV2005</secondary_id>
    <nct_id>NCT04453202</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels of an Ad26.RSV.preF-based Vaccine in Adults Aged 60 Years and Older</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>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 explore the dose-response relationship of immune responses&#xD;
      induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess&#xD;
      the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine&#xD;
      (Cohorts 2 and 3).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Actual">April 9, 2021</completion_date>
  <primary_completion_date type="Actual">September 24, 2020</primary_completion_date>
  <phase>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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cohort 1: RSV Fusion Protein (F Protein) Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA)</measure>
    <time_frame>14 days after vaccination (Day 15)</time_frame>
    <description>Antibodies binding to RSV F protein in pre-fusion form will be assessed by ELISA.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cohorts 2 and 3: Number of Participants with Solicited Local Adverse Events (AEs) After Vaccination</measure>
    <time_frame>7 days after vaccination (Day 1 to Day 8)</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. Solicited local AEs (including erythema, swelling, and pain/tenderness at the study vaccine injection site) will be noted in the participant diary after 7 days of vaccination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cohorts 2 and 3: Number of Participants with Solicited Systemic AEs After Vaccination</measure>
    <time_frame>7 days after vaccination (Day 1 to Day 8)</time_frame>
    <description>Solicited systemic AEs (fatigue, headache, myalgia, nausea and fever) will be noted in the participant diary after 7 days of vaccination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cohorts 2 and 3: Number of Participants with Unsolicited AEs After Vaccination</measure>
    <time_frame>28 days after vaccination (Day 1 to Day 29)</time_frame>
    <description>Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cohorts 1, 2 and 3: RSV preF Protein Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA)</measure>
    <time_frame>Cohort 1: Day 85 and 183; Cohorts 2 and 3: Day 15, 85 and 183</time_frame>
    <description>Antibodies binding to RSV F protein in pre-fusion form will be assessed by ELISA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohorts 1, 2 and 3: RSV A2 Neutralizing Antibody Levels</measure>
    <time_frame>Days 15, 85, and 183</time_frame>
    <description>Analysis of neutralizing antibodies to the A2 strain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohorts 1, 2 and 3: Interferon Gamma (IFN-gamma) Enzyme-Linked Immunospot (ELISpot) Assay</measure>
    <time_frame>Days 15, 85, and 183</time_frame>
    <description>RSV F-specific cellular immune responses elicited by the different vaccine regimens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohorts 1, 2 and 3: Number of Participants with Serious Adverse Events (SAEs)</measure>
    <time_frame>First vaccination (Day 1) to the end of the study (up to Day 183)</time_frame>
    <description>A SAE is any untoward medical occurrence that at any dose: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1: Number of Participants with Solicited Local AEs After Vaccination</measure>
    <time_frame>7 days after vaccination (Day 1 to Day 8)</time_frame>
    <description>Solicited local AEs (including erythema, swelling, and pain/tenderness at the study vaccine injection site) will be noted in the participant diary after 7 days of vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1: Number of Participants with Solicited Systemic AEs After Vaccination</measure>
    <time_frame>7 days after vaccination (Day 1 to Day 8)</time_frame>
    <description>Solicited systemic AEs (fatigue, headache, myalgia, nausea and fever) will be noted in the participant diary after 7 days of vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1: Number of Participants with Unsolicited AEs After Vaccination</measure>
    <time_frame>28 days after vaccination (Day 1 to Day 29)</time_frame>
    <description>Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.</description>
  </secondary_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Actual">459</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Cohort 1 Group 1: RSV Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single intramuscular (IM) injection of an Ad26-based RSV vaccine on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1 Group 2: RSV Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 1) on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1 Group 3: RSV Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 2) on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1 Group 4: RSV Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 3) on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1 Group 5: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive IM injection of placebo on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 Group 6: RSV Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 Group 7: RSV Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 1) on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 Group 8: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive IM injection of placebo on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3 Group 9: RSV Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3 Group 10: RSV Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 2) on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3 Group 11: Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive IM injection of placebo on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>RSV Vaccine</intervention_name>
    <description>Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.</description>
    <arm_group_label>Cohort 1 Group 1: RSV Vaccine</arm_group_label>
    <arm_group_label>Cohort 1 Group 2: RSV Vaccine</arm_group_label>
    <arm_group_label>Cohort 1 Group 3: RSV Vaccine</arm_group_label>
    <arm_group_label>Cohort 1 Group 4: RSV Vaccine</arm_group_label>
    <arm_group_label>Cohort 2 Group 6: RSV Vaccine</arm_group_label>
    <arm_group_label>Cohort 2 Group 7: RSV Vaccine</arm_group_label>
    <arm_group_label>Cohort 3 Group 10: RSV Vaccine</arm_group_label>
    <arm_group_label>Cohort 3 Group 9: RSV Vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive a single IM injection of placebo on Day 1.</description>
    <arm_group_label>Cohort 1 Group 5: Placebo</arm_group_label>
    <arm_group_label>Cohort 2 Group 8: Placebo</arm_group_label>
    <arm_group_label>Cohort 3 Group 11: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In the investigator's clinical judgment, participants must be either in good or stable&#xD;
             health. Participants may have underlying illnesses such as hypertension, type 2&#xD;
             diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their signs and&#xD;
             symptoms are stable and medically controlled in the judgment of the investigator.&#xD;
             Participants will be included on the basis of medical history and of physical&#xD;
             examination and vital signs performed at screening (all cohorts), and of physical&#xD;
             examination and/or vital signs performed prevaccination on Day 1 (Cohorts 2 and 3)&#xD;
&#xD;
          -  A woman must be postmenopausal (defined as no menses for 12 months without an&#xD;
             alternative medical cause) and not intending to conceive by any methods&#xD;
&#xD;
          -  Agree to not donate blood from the time of vaccination until 3 months after&#xD;
             vaccination&#xD;
&#xD;
          -  Have a body mass index (BMI) less than (&lt;) 40 kilogram per meter square (kg/m^2)&#xD;
&#xD;
          -  Be willing to provide verifiable identification and have means to be contacted and to&#xD;
             contact the investigator during the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a contraindication to intramuscular injection (IM) injections and blood draws&#xD;
             (example, bleeding disorders)&#xD;
&#xD;
          -  Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines&#xD;
             or vaccine components (including any of the constituents of the study vaccine)&#xD;
&#xD;
          -  History of chronic urticaria (recurrent hives), eczema, or atopic dermatitis&#xD;
&#xD;
          -  Has hepatitis B or C infection, including history of treated hepatitis C infection&#xD;
&#xD;
          -  Received an active RSV vaccine in a previous RSV vaccine study or an Ad26-vectored&#xD;
             vaccine at any time prior to randomization&#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 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>Optimal Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of South Florida, an AMR Company</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Research Associates, an AMR Company</name>
      <address>
        <city>El Dorado</city>
        <state>Kansas</state>
        <zip>67042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimal Research</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Pharmaceutical Research (CPR)</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research, LLC</name>
      <address>
        <city>Norfolk</city>
        <state>Nebraska</state>
        <zip>68701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research - Omaha</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tekton Research Inc.</name>
      <address>
        <city>Yukon</city>
        <state>Oklahoma</state>
        <zip>73099</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <disposition_first_submitted>September 23, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>September 23, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 28, 2021</disposition_first_posted>
  <last_update_submitted>September 23, 2021</last_update_submitted>
  <last_update_submitted_qc>September 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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. 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>
  <pending_results>
    <submitted>August 14, 2023</submitted>
    <returned>September 8, 2023</returned>
  </pending_results>
  <!-- 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/NCT04453202
org study id: CR108835
secondary id: VAC18193RSV2005
nct id: NCT04453202
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to explore the dose-response relationship of immune responses
      induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess
      the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine
      (Cohorts 2 and 3).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Cohort 1: RSV Fusion Protein (F Protein) Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA)
time frame: 14 days after vaccination (Day 15)
description: Antibodies binding to RSV F protein in pre-fusion form will be assessed by ELISA.
measure: Cohorts 2 and 3: Number of Participants with Solicited Local Adverse Events (AEs) After Vaccination
time frame: 7 days after vaccination (Day 1 to Day 8)
description: An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. Solicited local AEs (including erythema, swelling, and pain/tenderness at the study vaccine injection site) will be noted in the participant diary after 7 days of vaccination.
measure: Cohorts 2 and 3: Number of Participants with Solicited Systemic AEs After Vaccination
time frame: 7 days after vaccination (Day 1 to Day 8)
description: Solicited systemic AEs (fatigue, headache, myalgia, nausea and fever) will be noted in the participant diary after 7 days of vaccination.
measure: Cohorts 2 and 3: Number of Participants with Unsolicited AEs After Vaccination
time frame: 28 days after vaccination (Day 1 to Day 29)
description: Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.
measure: Cohorts 1, 2 and 3: RSV preF Protein Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA)
time frame: Cohort 1: Day 85 and 183; Cohorts 2 and 3: Day 15, 85 and 183
description: Antibodies binding to RSV F protein in pre-fusion form will be assessed by ELISA.
measure: Cohorts 1, 2 and 3: RSV A2 Neutralizing Antibody Levels
time frame: Days 15, 85, and 183
description: Analysis of neutralizing antibodies to the A2 strain.
measure: Cohorts 1, 2 and 3: Interferon Gamma (IFN-gamma) Enzyme-Linked Immunospot (ELISpot) Assay
time frame: Days 15, 85, and 183
description: RSV F-specific cellular immune responses elicited by the different vaccine regimens.
measure: Cohorts 1, 2 and 3: Number of Participants with Serious Adverse Events (SAEs)
time frame: First vaccination (Day 1) to the end of the study (up to Day 183)
description: A SAE is any untoward medical occurrence that at any dose: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
measure: Cohort 1: Number of Participants with Solicited Local AEs After Vaccination
time frame: 7 days after vaccination (Day 1 to Day 8)
description: Solicited local AEs (including erythema, swelling, and pain/tenderness at the study vaccine injection site) will be noted in the participant diary after 7 days of vaccination.
measure: Cohort 1: Number of Participants with Solicited Systemic AEs After Vaccination
time frame: 7 days after vaccination (Day 1 to Day 8)
description: Solicited systemic AEs (fatigue, headache, myalgia, nausea and fever) will be noted in the participant diary after 7 days of vaccination.
measure: Cohort 1: Number of Participants with Unsolicited AEs After Vaccination
time frame: 28 days after vaccination (Day 1 to Day 29)
description: Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.
arm group label: Cohort 1 Group 1: RSV Vaccine
arm group type: Experimental
description: Participants will receive a single intramuscular (IM) injection of an Ad26-based RSV vaccine on Day 1.
arm group label: Cohort 1 Group 2: RSV Vaccine
arm group type: Experimental
description: Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 1) on Day 1.
arm group label: Cohort 1 Group 3: RSV Vaccine
arm group type: Experimental
description: Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 2) on Day 1.
arm group label: Cohort 1 Group 4: RSV Vaccine
arm group type: Experimental
description: Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 3) on Day 1.
arm group label: Cohort 1 Group 5: Placebo
arm group type: Placebo Comparator
description: Participants will receive IM injection of placebo on Day 1.
arm group label: Cohort 2 Group 6: RSV Vaccine
arm group type: Experimental
description: Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
arm group label: Cohort 2 Group 7: RSV Vaccine
arm group type: Experimental
description: Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 1) on Day 1.
arm group label: Cohort 2 Group 8: Placebo
arm group type: Placebo Comparator
description: Participants will receive IM injection of placebo on Day 1.
arm group label: Cohort 3 Group 9: RSV Vaccine
arm group type: Experimental
description: Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
arm group label: Cohort 3 Group 10: RSV Vaccine
arm group type: Experimental
description: Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 2) on Day 1.
arm group label: Cohort 3 Group 11: Placebo
arm group type: Experimental
description: Participants will receive IM injection of placebo on Day 1.
intervention type: Biological
intervention name: RSV Vaccine
description: Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
arm group label: Cohort 1 Group 1: RSV Vaccine
arm group label: Cohort 1 Group 2: RSV Vaccine
arm group label: Cohort 1 Group 3: RSV Vaccine
arm group label: Cohort 1 Group 4: RSV Vaccine
arm group label: Cohort 2 Group 6: RSV Vaccine
arm group label: Cohort 2 Group 7: RSV Vaccine
arm group label: Cohort 3 Group 10: RSV Vaccine
arm group label: Cohort 3 Group 9: RSV Vaccine
intervention type: Other
intervention name: Placebo
description: Participants will receive a single IM injection of placebo on Day 1.
arm group label: Cohort 1 Group 5: Placebo
arm group label: Cohort 2 Group 8: Placebo
arm group label: Cohort 3 Group 11: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: Study Director
affiliation: Janssen Vaccines & Prevention B.V.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
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
submitted: August 14, 2023
returned: September 8, 2023