<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/NCT03303625</url>
  </required_header>
  <id_info>
    <org_study_id>CR108371</org_study_id>
    <secondary_id>2017-001345-27</secondary_id>
    <secondary_id>VAC18194RSV2001</secondary_id>
    <nct_id>NCT03303625</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety, Tolerability and Immunogenicity of an Investigational RSV Vaccine Candidate (Ad26.RSV.preF) in Adults 18 to 50 Years of Age, and RSV-seropositive Toddlers 12 to 24 Months of Age</brief_title>
  <official_title>A Randomized, Double-blind, Phase 1/2a Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.preF in Adults 18 to 50 Years of Age, RSV-seropositive Toddlers 12 to 24 Months of Age</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>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and tolerability of an intramuscular&#xD;
      regimen of two doses (1*10^11 viral particles [vp]) of an investigational respiratory&#xD;
      syncytial virus (RSV) vaccine candidate (adenovirus serotype 26 respiratory syncytial virus&#xD;
      pre-fusion conformation stabilized F protein [pre-F] [Ad26.RSV.preF]) in adults aged 18 to 50&#xD;
      years and RSV-seropositive toddlers aged 12 to 24 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study, designed to assess the safety and tolerability of two doses given one month apart&#xD;
      of Ad26.RSV.preF, an investigational RSV vaccine candidate based on a Ad26 vector expressing&#xD;
      the RSV F protein, will be conducted in a double blinded manner. The study will be divided in&#xD;
      two sequential cohorts: cohort 0 (18-50 year-old adults) and cohort 1 (12-24 month-old RSV&#xD;
      seropositive toddlers). The vaccine safety will be monitored by reporting solicited and&#xD;
      unsolicited adverse events (AEs) and all serious adverse events (SAEs). The data will be&#xD;
      reviewed by an independent data monitoring committee (IDMC) to assess safety data and to&#xD;
      ensure the continuing safety of the participants enrolled in this study. The safety will be&#xD;
      monitored throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2017</start_date>
  <completion_date type="Actual">April 21, 2020</completion_date>
  <primary_completion_date type="Actual">April 21, 2020</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>Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination</measure>
    <time_frame>For 7 days after first vaccination on Day 1 (Up to Day 7)</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination</measure>
    <time_frame>For 7 days after second vaccination on Day 29 (Up to Day 35)</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination</measure>
    <time_frame>For 7 days after first vaccination on Day 1 (Up to Day 7)</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature &gt;=38 degree celsius [°C]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature &gt;=38 °C).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination</measure>
    <time_frame>For 7 days after second vaccination on Day 29 (Up to Day 35)</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature &gt;=38 degree celsius [°C]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature &gt;=38 °C).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination</measure>
    <time_frame>For 28 days after first vaccination on Day 1 (Up to Day 28)</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included 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 Unsolicited Adverse Events for 28 Days After Second Vaccination</measure>
    <time_frame>For 28 days after second vaccination on Day 29 (Up to Day 56)</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included 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>From Day 1 (post-vaccination) to end of the study (up to 2 years 4 months)</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211</measure>
    <time_frame>Day 1 (predose), Post-dose on Days 29, 57 and 211</time_frame>
    <description>RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211</measure>
    <time_frame>Pre-fusion on Days 1, 29, 57 and 211</time_frame>
    <description>GMT (ELISA units per liter [EU/L]) of RSV F protein in pre-fusion form as assessed by ELISA was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211</measure>
    <time_frame>Post-fusion on Days 1, 29, 57 and 211</time_frame>
    <description>GMT (ELISA units per liter [EU/L]) of RSV F protein in post-fusion form as assessed by ELISA was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57</measure>
    <time_frame>Day 1 (predose) and Post-dose on Days, 29, and 57</time_frame>
    <description>Total cytokine response (CD4, CD8, Th1 and Th2 Cytokines) after in vitro RSV F protein peptide stimulation was reported as the percentage of CD4+ and CD8+ T cells that produce at least 1 of 3 cytokines.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Respiratory Syncytial Viruses</condition>
  <condition>Respiratory Tract Infections</condition>
  <arm_group>
    <arm_group_label>Cohort 0: Adults (Ad26.RSV.preF)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants aged greater than or equal to (&gt;=) 18 to lesser than or equal to (&lt;=) 50 years will receive vector Ad26.RSV.preF at 1*10^11 viral particles (vp) via intramuscular (IM) route (Group 1) on Day 1 and 29.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 0: Adults (Placebo)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants aged &gt;= 18 to &lt;= 50 years will receive placebo via IM route (Group 2) on Day 1 and 29.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1: RSV seropositive Toddlers (Ad26.RSV.preF)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RSV seropositive participants aged &gt;=12 to &lt;=24 months will receive Ad26.RSV.preF at 5*10^10 vp via IM route (Group 3) on Day 1 and 29.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1: RSV seropositive Toddlers (Placebo)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>RSV seropositive participants aged &gt;= 12 to &lt;= 24 months will receive placebo via IM route (Group 4) on Day 1 and 29.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ad26.RSV.preF (1*10^11 vp)</intervention_name>
    <description>Participants will receive two doses of 0.5 milliliter (mL) (1*10^11 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.</description>
    <arm_group_label>Cohort 0: Adults (Ad26.RSV.preF)</arm_group_label>
    <other_name>JNJ-64400141</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ad26.RSV.preF (5*10^10 vp)</intervention_name>
    <description>RSV seropositive participants will receive two doses of 0.25 mL (5*10^10 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.</description>
    <arm_group_label>Cohort 1: RSV seropositive Toddlers (Ad26.RSV.preF)</arm_group_label>
    <other_name>JNJ-64400141</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive either 0.5 mL (cohort 0) or 0.25 mL (cohort 1) of placebo via IM route on Day 1 and 29.</description>
    <arm_group_label>Cohort 0: Adults (Placebo)</arm_group_label>
    <arm_group_label>Cohort 1: RSV seropositive Toddlers (Placebo)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adults Participants:&#xD;
&#xD;
          -  Participant must be in good health, without significant medical illness, on the basis&#xD;
             of physical examination, medical history, and vital signs measurement&#xD;
&#xD;
          -  Participant must be healthy on the basis of clinical laboratory tests performed at&#xD;
             screening. If the results of the laboratory screening tests are outside the local&#xD;
             laboratory normal reference ranges and additionally within the limits of toxicity&#xD;
             Grade 1 according to the United stated (US) Food and Drug Administration (FDA)&#xD;
             toxicity tables, the participant may be included only if the investigator judges the&#xD;
             abnormalities or deviations from normal to be not clinically significant and&#xD;
             appropriate and reasonable for the population under study. This determination must be&#xD;
             recorded in the participant's source documents and initialed by the investigator&#xD;
&#xD;
          -  All women of childbearing potential must have a negative highly sensitive serum&#xD;
             beta-human chorionic gonadotropin (Beta-hCG) pregnancy test at screening and a&#xD;
             negative urine Beta-hCG pregnancy test immediately prior to each study vaccine&#xD;
             administration&#xD;
&#xD;
        Pediatric Participants:&#xD;
&#xD;
          -  Participant is the product of a normal term pregnancy greater than and equal to (&gt;=)&#xD;
             37 weeks, with a minimum birth weight of 2.5 kilogram (kg)&#xD;
&#xD;
          -  Participants must be in good health without any significant medical illness on the&#xD;
             basis of physical examination, medical history, and vital signs performed at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Adults Participants:&#xD;
&#xD;
          -  Participant has acute illness (this does not include minor illnesses such as diarrhea)&#xD;
             or temperature &gt;=38.0 ºC (degree celsius)/100.4 °F (fahrenheit) within 24 hours prior&#xD;
             to the first dose of study vaccine&#xD;
&#xD;
          -  Participant has a history of an underlying clinically significant acute or chronic&#xD;
             medical condition or physical examination findings for which, in the opinion of the&#xD;
             investigator, participation would not be in the best interest of the participant&#xD;
             (example, compromise the well-being) or that could prevent, limit, or confound the&#xD;
             protocol-specified assessments&#xD;
&#xD;
          -  Participant has history of malignancy within 5 years before screening (exceptions are&#xD;
             squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or&#xD;
             malignancy, which is considered cured with minimal risk of recurrence)&#xD;
&#xD;
        Pediatric Participants:&#xD;
&#xD;
          -  Participant's weight is below 10th percentile according to World Health Organization&#xD;
             (WHO) pediatric growth and weight charts&#xD;
&#xD;
          -  Participant has any clinically significant acute or chronic medical condition that, in&#xD;
             the opinion of the investigator, would preclude participation: example, history of&#xD;
             seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy,&#xD;
             systemic infections, congenital heart disease, history of any pulmonary condition&#xD;
             requiring medication, atopy, reactive airway disease, medically-confirmed wheezing,&#xD;
             bronchoconstriction or treatment with a beta2 agonist, cystic fibrosis,&#xD;
             bronchopulmonary dysplasia, chronic pulmonary disease, medically-confirmed apnea,&#xD;
             hospitalization for respiratory illness, or mechanical ventilation for respiratory&#xD;
             illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>50 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>Heartland Research Associates, LLC</name>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <zip>67114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Järvenpään rokotetutkimusklinikka</name>
      <address>
        <city>Järvenpää</city>
        <zip>04400</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tampere/Vaccine Research Center</name>
      <address>
        <city>Tampere</city>
        <zip>33100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tampere/Vaccine Research Center</name>
      <address>
        <city>Turku</city>
        <zip>20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Manchester Children's Hospital</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxford Vaccine Group</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Southampton NHS Foundation Trust</name>
      <address>
        <city>Southampton</city>
        <zip>SO166YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <results_first_submitted>April 19, 2023</results_first_submitted>
  <results_first_submitted_qc>May 30, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 23, 2023</results_first_posted>
  <disposition_first_submitted>April 20, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>May 30, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 23, 2023</disposition_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 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>Respiratory Tract Infections</mesh_term>
  </condition_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. 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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03303625/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03303625/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cohort 0 (Adults): Ad26.RSV.preF</title>
          <description>Adult participants aged greater than or equal to (&gt;=) 18 years to less than or equal to (&lt;=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 0 (Adults): Placebo</title>
          <description>Adult participants aged &gt;=18 years to &lt;=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.</description>
        </group>
        <group group_id="P3">
          <title>Cohort 1 (Toddlers): Ad26.RSV.preF</title>
          <description>Respiratory syncytial virus (RSV) seropositive toddler participants aged &gt;=12 to &lt;=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.</description>
        </group>
        <group group_id="P4">
          <title>Cohort 1 (Toddlers): Placebo</title>
          <description>RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="24"/>
                <participants group_id="P4" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="24"/>
                <participants group_id="P4" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cohort 0 (Adults): Ad26.RSV.preF</title>
          <description>Adult participants aged greater than or equal to (&gt;=) 18 years to less than or equal to (&lt;=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 0 (Adults): Placebo</title>
          <description>Adult participants aged &gt;=18 years to &lt;=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.</description>
        </group>
        <group group_id="B3">
          <title>Cohort 1 (Toddlers): Ad26.RSV.preF</title>
          <description>Respiratory syncytial virus (RSV) seropositive toddler participants aged &gt;=12 to &lt;=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.</description>
        </group>
        <group group_id="B4">
          <title>Cohort 1 (Toddlers): Placebo</title>
          <description>RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="24"/>
            <count group_id="B4" value="12"/>
            <count group_id="B5" value="48"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>FINLAND</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UNITED KINGDOM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UNITED STATES</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.</description>
        <time_frame>For 7 days after first vaccination on Day 1 (Up to Day 7)</time_frame>
        <population>The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 0 (Adults): Ad26.RSV.preF</title>
            <description>Adult participants aged greater than or equal to (&gt;=) 18 years to less than or equal to (&lt;=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 0 (Adults): Placebo</title>
            <description>Adult participants aged &gt;=18 years to &lt;=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 1 (Toddlers): Ad26.RSV.preF</title>
            <description>Respiratory syncytial virus (RSV) seropositive toddler participants aged &gt;=12 to &lt;=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 (Toddlers): Placebo</title>
            <description>RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.</description>
          <population>The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.</description>
        <time_frame>For 7 days after second vaccination on Day 29 (Up to Day 35)</time_frame>
        <population>The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. Here, 'N' (number of participant analyzed) signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 0 (Adults): Ad26.RSV.preF</title>
            <description>Adult participants aged greater than or equal to (&gt;=) 18 years to less than or equal to (&lt;=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 0 (Adults): Placebo</title>
            <description>Adult participants aged &gt;=18 years to &lt;=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 1 (Toddlers): Ad26.RSV.preF</title>
            <description>Respiratory syncytial virus (RSV) seropositive toddler participants aged &gt;=12 to &lt;=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 (Toddlers): Placebo</title>
            <description>RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.</description>
          <population>The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. Here, 'N' (number of participant analyzed) signifies number of participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature &gt;=38 degree celsius [°C]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature &gt;=38 °C).</description>
        <time_frame>For 7 days after first vaccination on Day 1 (Up to Day 7)</time_frame>
        <population>The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 0 (Adults): Ad26.RSV.preF</title>
            <description>Adult participants aged greater than or equal to (&gt;=) 18 years to less than or equal to (&lt;=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 0 (Adults): Placebo</title>
            <description>Adult participants aged &gt;=18 years to &lt;=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 1 (Toddlers): Ad26.RSV.preF</title>
            <description>Respiratory syncytial virus (RSV) seropositive toddler participants aged &gt;=12 to &lt;=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 (Toddlers): Placebo</title>
            <description>RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature &gt;=38 degree celsius [°C]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature &gt;=38 °C).</description>
          <population>The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature &gt;=38 degree celsius [°C]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature &gt;=38 °C).</description>
        <time_frame>For 7 days after second vaccination on Day 29 (Up to Day 35)</time_frame>
        <population>The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. Here, 'N' (number of participant analyzed) signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 0 (Adults): Ad26.RSV.preF</title>
            <description>Adult participants aged greater than or equal to (&gt;=) 18 years to less than or equal to (&lt;=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 0 (Adults): Placebo</title>
            <description>Adult participants aged &gt;=18 years to &lt;=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 1 (Toddlers): Ad26.RSV.preF</title>
            <description>Respiratory syncytial virus (RSV) seropositive toddler participants aged &gt;=12 to &lt;=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 (Toddlers): Placebo</title>
            <description>RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature &gt;=38 degree celsius [°C]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature &gt;=38 °C).</description>
          <population>The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. Here, 'N' (number of participant analyzed) signifies number of participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="22"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.</description>
        <time_frame>For 28 days after first vaccination on Day 1 (Up to Day 28)</time_frame>
        <population>The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 0 (Adults): Ad26.RSV.preF</title>
            <description>Adult participants aged greater than or equal to (&gt;=) 18 years to less than or equal to (&lt;=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 0 (Adults): Placebo</title>
            <description>Adult participants aged &gt;=18 years to &lt;=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 1 (Toddlers): Ad26.RSV.preF</title>
            <description>Respiratory syncytial virus (RSV) seropositive toddler participants aged &gt;=12 to &lt;=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 (Toddlers): Placebo</title>
            <description>RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.</description>
          <population>The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.</description>
        <time_frame>For 28 days after second vaccination on Day 29 (Up to Day 56)</time_frame>
        <population>The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. Here, 'N' (number of participant analyzed) signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 0 (Adults): Ad26.RSV.preF</title>
            <description>Adult participants aged greater than or equal to (&gt;=) 18 years to less than or equal to (&lt;=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 0 (Adults): Placebo</title>
            <description>Adult participants aged &gt;=18 years to &lt;=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 1 (Toddlers): Ad26.RSV.preF</title>
            <description>Respiratory syncytial virus (RSV) seropositive toddler participants aged &gt;=12 to &lt;=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 (Toddlers): Placebo</title>
            <description>RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.</description>
          <population>The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. Here, 'N' (number of participant analyzed) signifies number of participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Serious Adverse Events (SAEs)</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.</description>
        <time_frame>From Day 1 (post-vaccination) to end of the study (up to 2 years 4 months)</time_frame>
        <population>The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 0 (Adults): Ad26.RSV.preF</title>
            <description>Adult participants aged greater than or equal to (&gt;=) 18 years to less than or equal to (&lt;=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 0 (Adults): Placebo</title>
            <description>Adult participants aged &gt;=18 years to &lt;=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 1 (Toddlers): Ad26.RSV.preF</title>
            <description>Respiratory syncytial virus (RSV) seropositive toddler participants aged &gt;=12 to &lt;=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 (Toddlers): Placebo</title>
            <description>RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events (SAEs)</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.</description>
          <population>The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211</title>
        <description>RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.</description>
        <time_frame>Day 1 (predose), Post-dose on Days 29, 57 and 211</time_frame>
        <population>The Per-protocol Immunogenicity (PPI) set included all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies the number of participants evaluable at a specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 0 (Adults): Ad26.RSV.preF</title>
            <description>Adult participants aged greater than or equal to (&gt;=) 18 years to less than or equal to (&lt;=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 0 (Adults): Placebo</title>
            <description>Adult participants aged &gt;=18 years to &lt;=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 1 (Toddlers): Ad26.RSV.preF</title>
            <description>Respiratory syncytial virus (RSV) seropositive toddler participants aged &gt;=12 to &lt;=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 (Toddlers): Placebo</title>
            <description>RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211</title>
          <description>RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.</description>
          <population>The Per-protocol Immunogenicity (PPI) set included all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies the number of participants evaluable at a specified timepoint.</population>
          <units>Titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (pre-dose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="329" lower_limit="252" upper_limit="431"/>
                    <measurement group_id="O2" value="547" lower_limit="86" upper_limit="3489"/>
                    <measurement group_id="O3" value="121" lower_limit="76" upper_limit="191"/>
                    <measurement group_id="O4" value="187" lower_limit="100" upper_limit="349"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post dose 1: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1089" lower_limit="483" upper_limit="2456"/>
                    <measurement group_id="O2" value="603" lower_limit="101" upper_limit="3596"/>
                    <measurement group_id="O3" value="1608" lower_limit="730" upper_limit="3544"/>
                    <measurement group_id="O4" value="156" lower_limit="68" upper_limit="358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post dose 2: Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="926" lower_limit="485" upper_limit="1769"/>
                    <measurement group_id="O2" value="566" lower_limit="114" upper_limit="2805"/>
                    <measurement group_id="O3" value="2235" lower_limit="1586" upper_limit="3150"/>
                    <measurement group_id="O4" value="198" lower_limit="89" upper_limit="441"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post dose 2: Day 211</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="16"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="704" lower_limit="325" upper_limit="1526"/>
                    <measurement group_id="O2" value="574" lower_limit="139" upper_limit="2374"/>
                    <measurement group_id="O3" value="1164" lower_limit="734" upper_limit="1847"/>
                    <measurement group_id="O4" value="165" lower_limit="70" upper_limit="387"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211</title>
        <description>GMT (ELISA units per liter [EU/L]) of RSV F protein in pre-fusion form as assessed by ELISA was reported.</description>
        <time_frame>Pre-fusion on Days 1, 29, 57 and 211</time_frame>
        <population>The PPI set included all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies the number of participants evaluable at a specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 0 (Adults): Ad26.RSV.preF</title>
            <description>Adult participants aged greater than or equal to (&gt;=) 18 years to less than or equal to (&lt;=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 0 (Adults): Placebo</title>
            <description>Adult participants aged &gt;=18 years to &lt;=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 1 (Toddlers): Ad26.RSV.preF</title>
            <description>Respiratory syncytial virus (RSV) seropositive toddler participants aged &gt;=12 to &lt;=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 (Toddlers): Placebo</title>
            <description>RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211</title>
          <description>GMT (ELISA units per liter [EU/L]) of RSV F protein in pre-fusion form as assessed by ELISA was reported.</description>
          <population>The PPI set included all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies the number of participants evaluable at a specified timepoint.</population>
          <units>EU/L</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="197" lower_limit="132" upper_limit="295"/>
                    <measurement group_id="O2" value="249" lower_limit="50" upper_limit="1234"/>
                    <measurement group_id="O3" value="59" lower_limit="36" upper_limit="97"/>
                    <measurement group_id="O4" value="113" lower_limit="57" upper_limit="223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="441" lower_limit="304" upper_limit="639"/>
                    <measurement group_id="O2" value="261" lower_limit="60" upper_limit="1138"/>
                    <measurement group_id="O3" value="1174" lower_limit="524" upper_limit="2630"/>
                    <measurement group_id="O4" value="106" lower_limit="56" upper_limit="199"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="481" lower_limit="317" upper_limit="729"/>
                    <measurement group_id="O2" value="244" lower_limit="60" upper_limit="992"/>
                    <measurement group_id="O3" value="1918" lower_limit="1497" upper_limit="2456"/>
                    <measurement group_id="O4" value="148" lower_limit="54" upper_limit="402"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 211</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="16"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="418" lower_limit="264" upper_limit="664"/>
                    <measurement group_id="O2" value="292" lower_limit="45" upper_limit="1895"/>
                    <measurement group_id="O3" value="924" lower_limit="639" upper_limit="1334"/>
                    <measurement group_id="O4" value="120" lower_limit="39" upper_limit="370"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211</title>
        <description>GMT (ELISA units per liter [EU/L]) of RSV F protein in post-fusion form as assessed by ELISA was reported.</description>
        <time_frame>Post-fusion on Days 1, 29, 57 and 211</time_frame>
        <population>The PPI set included all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies the number of participants evaluable at a specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 0 (Adults): Ad26.RSV.preF</title>
            <description>Adult participants aged greater than or equal to (&gt;=) 18 years to less than or equal to (&lt;=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 0 (Adults): Placebo</title>
            <description>Adult participants aged &gt;=18 years to &lt;=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 1 (Toddlers): Ad26.RSV.preF</title>
            <description>Respiratory syncytial virus (RSV) seropositive toddler participants aged &gt;=12 to &lt;=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 (Toddlers): Placebo</title>
            <description>RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211</title>
          <description>GMT (ELISA units per liter [EU/L]) of RSV F protein in post-fusion form as assessed by ELISA was reported.</description>
          <population>The PPI set included all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies the number of participants evaluable at a specified timepoint.</population>
          <units>EU/L</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="196" lower_limit="112" upper_limit="346"/>
                    <measurement group_id="O2" value="191" lower_limit="19" upper_limit="1879"/>
                    <measurement group_id="O3" value="77" lower_limit="48" upper_limit="125"/>
                    <measurement group_id="O4" value="94" lower_limit="46" upper_limit="190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="328" lower_limit="207" upper_limit="521"/>
                    <measurement group_id="O2" value="207" lower_limit="25" upper_limit="1738"/>
                    <measurement group_id="O3" value="686" lower_limit="371" upper_limit="1268"/>
                    <measurement group_id="O4" value="86" lower_limit="47" upper_limit="158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="341" lower_limit="198" upper_limit="589"/>
                    <measurement group_id="O2" value="179" lower_limit="23" upper_limit="1370"/>
                    <measurement group_id="O3" value="863" lower_limit="630" upper_limit="1184"/>
                    <measurement group_id="O4" value="109" lower_limit="52" upper_limit="232"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 211</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="16"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="268" lower_limit="142" upper_limit="507"/>
                    <measurement group_id="O2" value="181" lower_limit="18" upper_limit="1870"/>
                    <measurement group_id="O3" value="420" lower_limit="306" upper_limit="576"/>
                    <measurement group_id="O4" value="91" lower_limit="33" upper_limit="256"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57</title>
        <description>Total cytokine response (CD4, CD8, Th1 and Th2 Cytokines) after in vitro RSV F protein peptide stimulation was reported as the percentage of CD4+ and CD8+ T cells that produce at least 1 of 3 cytokines.</description>
        <time_frame>Day 1 (predose) and Post-dose on Days, 29, and 57</time_frame>
        <population>PPI set: all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact immunogenicity outcomes. 'N' (number of participants analyzed)=number of participants who were evaluable for this outcome measure, 'n' (number analyzed)=number of participants evaluable at specified timepoint and '0' in number analyzed field=none of participants were applicable for evaluation at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 0 (Adults): Ad26.RSV.preF</title>
            <description>Adult participants aged greater than or equal to (&gt;=) 18 years to less than or equal to (&lt;=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 0 (Adults): Placebo</title>
            <description>Adult participants aged &gt;=18 years to &lt;=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 1 (Toddlers): Ad26.RSV.preF</title>
            <description>Respiratory syncytial virus (RSV) seropositive toddler participants aged &gt;=12 to &lt;=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 (Toddlers): Placebo</title>
            <description>RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57</title>
          <description>Total cytokine response (CD4, CD8, Th1 and Th2 Cytokines) after in vitro RSV F protein peptide stimulation was reported as the percentage of CD4+ and CD8+ T cells that produce at least 1 of 3 cytokines.</description>
          <population>PPI set: all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact immunogenicity outcomes. 'N' (number of participants analyzed)=number of participants who were evaluable for this outcome measure, 'n' (number analyzed)=number of participants evaluable at specified timepoint and '0' in number analyzed field=none of participants were applicable for evaluation at specified time point.</population>
          <units>Percentage of cytokine cell subsets</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CD4: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.058" lower_limit="0.057" upper_limit="0.067"/>
                    <measurement group_id="O2" value="0.054" lower_limit="0.048" upper_limit="0.108"/>
                    <measurement group_id="O3" value="0.030" lower_limit="0.013" upper_limit="0.095"/>
                    <measurement group_id="O4" value="0.050" lower_limit="0.015" upper_limit="0.079"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.168" lower_limit="0.100" upper_limit="0.210"/>
                    <measurement group_id="O2" value="0.058" lower_limit="0.051" upper_limit="0.082"/>
                    <measurement group_id="O3" value="0.089" lower_limit="0.062" upper_limit="0.131"/>
                    <measurement group_id="O4" value="0.074" lower_limit="0.056" upper_limit="0.123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4: Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.148" lower_limit="0.115" upper_limit="0.351"/>
                    <measurement group_id="O2" value="0.039" lower_limit="0.024" upper_limit="0.116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.041" lower_limit="0.033" upper_limit="0.084"/>
                    <measurement group_id="O2" value="0.075" lower_limit="0.005" upper_limit="0.141"/>
                    <measurement group_id="O3" value="0.033" lower_limit="0.024" upper_limit="0.049"/>
                    <measurement group_id="O4" value="0.041" lower_limit="0.025" upper_limit="0.081"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.145" lower_limit="0.080" upper_limit="0.233"/>
                    <measurement group_id="O2" value="0.092" lower_limit="0.022" upper_limit="0.105"/>
                    <measurement group_id="O3" value="0.077" lower_limit="0.024" upper_limit="0.116"/>
                    <measurement group_id="O4" value="0.053" lower_limit="0.016" upper_limit="0.110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8: Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.081" lower_limit="0.070" upper_limit="0.211"/>
                    <measurement group_id="O2" value="0.062" lower_limit="0.003" upper_limit="0.185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Th1: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.045" lower_limit="0.028" upper_limit="0.065"/>
                    <measurement group_id="O2" value="0.054" lower_limit="0.031" upper_limit="0.096"/>
                    <measurement group_id="O3" value="0.007" lower_limit="0.003" upper_limit="0.022"/>
                    <measurement group_id="O4" value="0.018" lower_limit="0.011" upper_limit="0.027"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Th1: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.098" lower_limit="0.040" upper_limit="0.146"/>
                    <measurement group_id="O2" value="0.049" lower_limit="0.037" upper_limit="0.057"/>
                    <measurement group_id="O3" value="0.034" lower_limit="0.025" upper_limit="0.078"/>
                    <measurement group_id="O4" value="0.028" lower_limit="0.017" upper_limit="0.055"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Th1: Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.112" lower_limit="0.083" upper_limit="0.302"/>
                    <measurement group_id="O2" value="0.039" lower_limit="0.008" upper_limit="0.061"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Th2: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.006" lower_limit="0.001" upper_limit="0.016"/>
                    <measurement group_id="O2" value="0.001" lower_limit="0.001" upper_limit="0.002"/>
                    <measurement group_id="O3" value="0.002" lower_limit="0.001" upper_limit="0.004"/>
                    <measurement group_id="O4" value="0.004" lower_limit="0.001" upper_limit="0.005"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Th2: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.003" lower_limit="0.002" upper_limit="0.006"/>
                    <measurement group_id="O2" value="0.001" lower_limit="0.001" upper_limit="0.001"/>
                    <measurement group_id="O3" value="0.005" lower_limit="0.001" upper_limit="0.007"/>
                    <measurement group_id="O4" value="0.003" lower_limit="0.002" upper_limit="0.007"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Th2: Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.003" lower_limit="0.001" upper_limit="0.022"/>
                    <measurement group_id="O2" value="0.001" lower_limit="0.001" upper_limit="0.001"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Day 1 (post-vaccination) up to end of the study (up to 2 years 4 months)</time_frame>
      <desc>The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort 0 (Adults): Ad26.RSV.preF</title>
          <description>Adult participants aged greater than or equal to (&gt;=) 18 years to less than or equal to (&lt;=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.</description>
        </group>
        <group group_id="E2">
          <title>Cohort 0 (Adults): Placebo</title>
          <description>Adult participants aged &gt;=18 years to &lt;=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.</description>
        </group>
        <group group_id="E3">
          <title>Cohort 1 (Toddlers): Ad26.RSV.preF</title>
          <description>Respiratory syncytial virus (RSV) seropositive toddler participants aged &gt;=12 to &lt;=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.</description>
        </group>
        <group group_id="E4">
          <title>Cohort 1 (Toddlers): Placebo</title>
          <description>RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 22.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA Version 22.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Teething</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Influenza Like Illness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to Animal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Anal Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Body Tinea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Enterovirus Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hand-Foot-And-Mouth Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Oral Herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Otitis Externa</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Otitis Media</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Skin Bacterial Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Tinea Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Viral Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Viral Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Viral Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Heart Rate Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Influenza B Virus Test Positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Lymphocyte Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Respiratory Syncytial Virus Test Positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Loss of Consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Rales</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Respiratory Tract Irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Rhonchi</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis Diaper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Miliaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Trial Physician</name_or_title>
      <organization>Janssen Vaccines and Prevention B.V.</organization>
      <phone>844-434-4210</phone>
      <email>ClinicalTrialDisclosure@its.jnj.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03303625
org study id: CR108371
secondary id: 2017-001345-27
secondary id: VAC18194RSV2001
nct id: NCT03303625
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to assess the safety and tolerability of an intramuscular
      regimen of two doses (1*10^11 viral particles [vp]) of an investigational respiratory
      syncytial virus (RSV) vaccine candidate (adenovirus serotype 26 respiratory syncytial virus
      pre-fusion conformation stabilized F protein [pre-F] [Ad26.RSV.preF]) in adults aged 18 to 50
      years and RSV-seropositive toddlers aged 12 to 24 months.
The study, designed to assess the safety and tolerability of two doses given one month apart
      of Ad26.RSV.preF, an investigational RSV vaccine candidate based on a Ad26 vector expressing
      the RSV F protein, will be conducted in a double blinded manner. The study will be divided in
      two sequential cohorts: cohort 0 (18-50 year-old adults) and cohort 1 (12-24 month-old RSV
      seropositive toddlers). The vaccine safety will be monitored by reporting solicited and
      unsolicited adverse events (AEs) and all serious adverse events (SAEs). The data will be
      reviewed by an independent data monitoring committee (IDMC) to assess safety data and to
      ensure the continuing safety of the participants enrolled in this study. The safety will be
      monitored throughout the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination
time frame: For 7 days after first vaccination on Day 1 (Up to Day 7)
description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.
measure: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination
time frame: For 7 days after second vaccination on Day 29 (Up to Day 35)
description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.
measure: Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination
time frame: For 7 days after first vaccination on Day 1 (Up to Day 7)
description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature >=38 degree celsius [°C]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature >=38 °C).
measure: Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination
time frame: For 7 days after second vaccination on Day 29 (Up to Day 35)
description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature >=38 degree celsius [°C]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature >=38 °C).
measure: Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination
time frame: For 28 days after first vaccination on Day 1 (Up to Day 28)
description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.
measure: Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination
time frame: For 28 days after second vaccination on Day 29 (Up to Day 56)
description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included 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: From Day 1 (post-vaccination) to end of the study (up to 2 years 4 months)
description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
measure: Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211
time frame: Day 1 (predose), Post-dose on Days 29, 57 and 211
description: RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.
measure: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211
time frame: Pre-fusion on Days 1, 29, 57 and 211
description: GMT (ELISA units per liter [EU/L]) of RSV F protein in pre-fusion form as assessed by ELISA was reported.
measure: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211
time frame: Post-fusion on Days 1, 29, 57 and 211
description: GMT (ELISA units per liter [EU/L]) of RSV F protein in post-fusion form as assessed by ELISA was reported.
measure: Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57
time frame: Day 1 (predose) and Post-dose on Days, 29, and 57
description: Total cytokine response (CD4, CD8, Th1 and Th2 Cytokines) after in vitro RSV F protein peptide stimulation was reported as the percentage of CD4+ and CD8+ T cells that produce at least 1 of 3 cytokines.
arm group label: Cohort 0: Adults (Ad26.RSV.preF)
arm group type: Experimental
description: Participants aged greater than or equal to (>=) 18 to lesser than or equal to (<=) 50 years will receive vector Ad26.RSV.preF at 1*10^11 viral particles (vp) via intramuscular (IM) route (Group 1) on Day 1 and 29.
arm group label: Cohort 0: Adults (Placebo)
arm group type: Placebo Comparator
description: Participants aged >= 18 to <= 50 years will receive placebo via IM route (Group 2) on Day 1 and 29.
arm group label: Cohort 1: RSV seropositive Toddlers (Ad26.RSV.preF)
arm group type: Experimental
description: RSV seropositive participants aged >=12 to <=24 months will receive Ad26.RSV.preF at 5*10^10 vp via IM route (Group 3) on Day 1 and 29.
arm group label: Cohort 1: RSV seropositive Toddlers (Placebo)
arm group type: Placebo Comparator
description: RSV seropositive participants aged >= 12 to <= 24 months will receive placebo via IM route (Group 4) on Day 1 and 29.
intervention type: Biological
intervention name: Ad26.RSV.preF (1*10^11 vp)
description: Participants will receive two doses of 0.5 milliliter (mL) (1*10^11 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.
arm group label: Cohort 0: Adults (Ad26.RSV.preF)
other name: JNJ-64400141
intervention type: Biological
intervention name: Ad26.RSV.preF (5*10^10 vp)
description: RSV seropositive participants will receive two doses of 0.25 mL (5*10^10 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.
arm group label: Cohort 1: RSV seropositive Toddlers (Ad26.RSV.preF)
other name: JNJ-64400141
intervention type: Drug
intervention name: Placebo
description: Participants will receive either 0.5 mL (cohort 0) or 0.25 mL (cohort 1) of placebo via IM route on Day 1 and 29.
arm group label: Cohort 0: Adults (Placebo)
arm group label: Cohort 1: RSV seropositive Toddlers (Placebo)
criteria: 
gender: All
minimum age: 12 Months
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: Study Director
affiliation: Janssen Vaccines & Prevention B.V.
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country: Finland
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Respiratory Tract Infections
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
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