<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/NCT04491877</url>
  </required_header>
  <id_info>
    <org_study_id>VAD00001</org_study_id>
    <secondary_id>U1111-1238-1869</secondary_id>
    <nct_id>NCT04491877</nct_id>
  </id_info>
  <brief_title>Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers</brief_title>
  <acronym>VAD00001</acronym>
  <official_title>Safety, Immunogenicity, Infectivity, and Dose-Finding Study of an Investigational Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Infants and Toddlers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi Pasteur, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of the study are:&#xD;
&#xD;
        -  To assess the safety profile of each dose of the study product after each and any&#xD;
           administration in all infants and toddlers regardless of baseline serostatus.&#xD;
&#xD;
        -  To characterize the Respiratory Syncytial Virus (RSV) A serum neutralizing antibody&#xD;
           responses to the study product in each vaccine group after vaccination in RSV-naïve&#xD;
           participants.&#xD;
&#xD;
      The secondary objectives of the study are:&#xD;
&#xD;
        -  To quantify the amount of vaccine virus shed by each participant by baseline serostatus.&#xD;
&#xD;
        -  To determine the proportion of vaccinated infants and toddlers in each vaccine group&#xD;
           infected with the vaccine virus at D56 (56 days after vaccination 1) for Cohorts 1, 2, 3&#xD;
           and 4, and at Day 84 (28 days after vaccination 2) for Cohorts 2 and 4 by baseline&#xD;
           serostatus.&#xD;
&#xD;
        -  To characterize the RSV A serum neutralizing antibody responses to the study product in&#xD;
           each vaccine group after vaccination in RSV-experienced participants.&#xD;
&#xD;
        -  To characterize serum RSV anti-F immunoglobulin G (IgG) antibody responses to the study&#xD;
           product in each vaccine group after vaccination by baseline serostatus.&#xD;
&#xD;
        -  To characterize serum RSV antibody responses (RSV A-neutralizing and anti-RSV F IgG) to&#xD;
           the study product in each vaccine group after the RSV surveillance season or at least 5&#xD;
           months after the last vaccine administration by baseline serostatus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study duration per participant is maximum 12 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 17, 2020</start_date>
  <completion_date type="Actual">April 13, 2023</completion_date>
  <primary_completion_date type="Actual">April 13, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The study is performed in an observer-blind fashion. Investigators and study staff who conduct the safety assessment and the participants do not know which vaccine is administered. Only the study staff who prepare and administer the vaccine and are not involved with the safety evaluation knows which vaccine is administered.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants reporting immediate adverse events</measure>
    <time_frame>Within 30 minutes after vaccination</time_frame>
    <description>Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants reporting solicited reactions</measure>
    <time_frame>Within 28 days after vaccination</time_frame>
    <description>Solicited administrative site reaction: rhinorrhea. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants reporting unsolicited adverse events</measure>
    <time_frame>Within 28 days after vaccination</time_frame>
    <description>Unsolicited adverse events are spontaneously reported adverse events.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants reporting adverse events of special interest</measure>
    <time_frame>Within 28 days after vaccination</time_frame>
    <description>Adverse events of special interest pre-defined adverse event collected using the same process as for other adverse events.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants reporting medically attended adverse events</measure>
    <time_frame>Within 28 days after vaccination</time_frame>
    <description>Medically attended adverse events are adverse events with a new onset or a worsening of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants reporting serious adverse events</measure>
    <time_frame>Day 0 to maximum Month 12</time_frame>
    <description>Serious adverse events are collected throughout the study, from Day 0 until the end of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RSV A serum neutralizing antibody levels after first vaccine administration</measure>
    <time_frame>Day 56</time_frame>
    <description>RSV A serum neutralizing antibody levels assessed in RSV-naïve participants in Cohorts 1, 2, 3, and 4.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RSV A serum neutralizing antibody levels after second vaccine administration</measure>
    <time_frame>Day 84</time_frame>
    <description>RSV A serum neutralizing antibody levels are assessed in RS-naïve participants in Cohorts 2 and 4.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Titer of vaccine virus shedding (polymerase chain reaction [RT-PCR])</measure>
    <time_frame>7 days after vaccination</time_frame>
    <description>Titers are assessed by PCR at Day 7 for Cohorts 1, 2, 3 and 4 and Day 63 for Cohorts 2 and 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants infected with the vaccine virus</measure>
    <time_frame>Day 56 and Day 84</time_frame>
    <description>Infection is defined as detection of vaccine in nasal wash by culture or PCR and / or a ≥ 4-fold rise in serum neutralizing antibodies or in serum antibodies to RSV F. Infectivity is assessed on Day 56 for Cohorts 1, 2, 3 and 4, and after vaccination 2 (Day 84) for Cohorts 2 and 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RSV A serum neutralizing antibody levels</measure>
    <time_frame>Day 56 and Day 84</time_frame>
    <description>RSV serum neutralizing antibody levels assessed in RSV-experienced participants on Day 56 for Cohorts 1, 2, 3 and 4, and after vaccination 2 (Day 84) for Cohorts 2 and 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RSV serum anti-F binding antibody levels</measure>
    <time_frame>Day 56 and Day 84</time_frame>
    <description>RSV serum anti-F binding antibody levels assessed on Day 56 for Cohorts 1, 2, 3 and 4, and after vaccination 2 (Day 84) for Cohorts 2 and 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RSV A serum neutralizing and serum anti-RSV F IgG antibody titers after the RSV surveillance season or at least 5 months after the last vaccine administration</measure>
    <time_frame>Within 1 month after the end of the RSV season or at least 5 months after the last vaccine administration.</time_frame>
    <description>RSV A serum neutralizing and serum anti-RSV F IgG antibody titers are assessed after the end of the RSV season (on average end of March in the Northern Hemisphere and end of September in the Southern Hemisphere) or at least 5 months after the last vaccine administration.</description>
  </secondary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">259</enrollment>
  <condition>Respiratory Syncytial Virus Infection</condition>
  <arm_group>
    <arm_group_label>Cohort 1 (RSV vaccine formulation 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 administration of RSV vaccine formulation 1 on Day 0</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1 (Placebo)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1 administration of placebo on Day 0</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 (RSV vaccine formulation 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 administrations of RSV vaccine formulation 1 on Day 0 and Day 56</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 (Placebo)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 administrations of placebo on Day 0 and Day 56</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3 (RSV vaccine formulation 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 administration of RSV vaccine formulation 2 on Day 0</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3 (Placebo)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1 administration of placebo on Day 0</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4 (RSV vaccine formulation 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 administrations of RSV vaccine formulation 1 on Day 0 and Day 56</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4 (RSV vaccine formulation 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 administrations of RSV vaccine formulation 2 on Day 0 and Day 56</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4 (Placebo)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 administrations of placebo on Day 0 and Day 56</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>RSV vaccine formulation 1</intervention_name>
    <description>Pharmaceutical form: Suspension of virus Route of administration: Intranasal</description>
    <arm_group_label>Cohort 1 (RSV vaccine formulation 1)</arm_group_label>
    <arm_group_label>Cohort 2 (RSV vaccine formulation 1)</arm_group_label>
    <arm_group_label>Cohort 4 (RSV vaccine formulation 1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>RSV vaccine formulation 2</intervention_name>
    <description>Pharmaceutical form: Suspension of virus Route of administration: Intranasal</description>
    <arm_group_label>Cohort 3 (RSV vaccine formulation 2)</arm_group_label>
    <arm_group_label>Cohort 4 (RSV vaccine formulation 2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Pharmaceutical form: Suspension Route of administration: Intranasal</description>
    <arm_group_label>Cohort 1 (Placebo)</arm_group_label>
    <arm_group_label>Cohort 2 (Placebo)</arm_group_label>
    <arm_group_label>Cohort 3 (Placebo)</arm_group_label>
    <arm_group_label>Cohort 4 (Placebo)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria :&#xD;
&#xD;
          -  Aged 6 through 18 months at Day 0.&#xD;
&#xD;
          -  Informed consent form has been signed and dated by the parent(s) or other legally&#xD;
             acceptable representative (and by independent witness if required by local&#xD;
             regulations).&#xD;
&#xD;
          -  Participant and parent / guardian / legally acceptable representative are able to&#xD;
             attend all scheduled visits and to comply with all trial procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Born at less than 34 weeks gestation&#xD;
&#xD;
          -  Born at less than 37 weeks gestation and less than 1 year of age at the time&#xD;
&#xD;
          -  Known or suspected congenital or acquired immunodeficiency; or receipt of&#xD;
             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,&#xD;
             within the preceding 6 months; or long-term systemic corticosteroid therapy&#xD;
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).&#xD;
&#xD;
          -  Probable or confirmed case of Coronavirus Disease 2019 (COVID-19).&#xD;
&#xD;
          -  Known systemic hypersensitivity to any of the vaccine components, or history of a&#xD;
             life-threatening reaction to the vaccine used in the trial or to a vaccine containing&#xD;
             any of the same substances&#xD;
&#xD;
          -  Any chronic illness&#xD;
&#xD;
             • Chronic illness may include, but is not limited to, cardiac disorders, lung disease&#xD;
             (including any history of reactive airway disease, receipt of bronchodilator therapy,&#xD;
             or medically diagnosed wheezing), renal disorders, auto-immune disorders, diabetes,&#xD;
             psychomotor diseases, and known congenital or genetic diseases&#xD;
&#xD;
          -  Any history of medically diagnosed wheezing&#xD;
&#xD;
          -  Any acute febrile, respiratory or gastrointestinal illness in the past 24 hours that&#xD;
             according to investigator judgment is significant enough to interfere with successful&#xD;
             inoculation on the day of vaccination. ebrile event has subsided&#xD;
&#xD;
          -  Any previous anaphylactic reaction&#xD;
&#xD;
          -  Current suspected or documented developmental disorder, delay, or other developmental&#xD;
             problem&#xD;
&#xD;
          -  Receipt of any of the following vaccines prior to enrollment:&#xD;
&#xD;
               -  any influenza vaccine within 7 days prior, or&#xD;
&#xD;
               -  any inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days&#xD;
                  prior, or&#xD;
&#xD;
               -  any live vaccine, other than rotavirus vaccine, within the 28 days prior, or&#xD;
&#xD;
               -  another investigational vaccine or investigational drug within 28 days prior&#xD;
&#xD;
          -  Previous receipt of a licensed or investigational RSV vaccine or previous receipt or&#xD;
             planned administration of any anti-RSV product (such as ribavirin or RSV immune immune&#xD;
             globulins [IG] or RSV monoclonal antibody)&#xD;
&#xD;
          -  Receipt of immune globulins, blood or blood-derived products in the past 6 months&#xD;
             prior to enrolment&#xD;
&#xD;
          -  Receipt of any of the following medications within 3 days prior to study enrollment&#xD;
             (Day 0):&#xD;
&#xD;
               -  systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous&#xD;
                  agents, whether for treatment or prophylaxis, or&#xD;
&#xD;
               -  intranasal medications, or&#xD;
&#xD;
               -  other prescription medication except as permitted concomitant medications&#xD;
                  (prescription or non-prescription) including nutritional supplements, medications&#xD;
                  for gastroesophageal reflux, eye drops, and topical medications, including (but&#xD;
                  not limited to) cutaneous (topical) steroids, topical antibiotics, and topical&#xD;
                  antifungal agents&#xD;
&#xD;
          -  Receipt of salicylate (aspirin) or salicylate-containing products within the 28 days&#xD;
             prior to enrollment (Day 0)&#xD;
&#xD;
          -  Any previous vaccine-associated adverse reaction that was Grade 3 or above. Note: if&#xD;
             grading is not possible, determine if the reaction was considered severe or life&#xD;
             threatening; if so, it is exclusionary.&#xD;
&#xD;
          -  Scheduled administration of the following after planned inoculation:&#xD;
&#xD;
               -  any influenza vaccine within 7 days after, or&#xD;
&#xD;
               -  inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days&#xD;
                  after, or&#xD;
&#xD;
               -  any live vaccine other than rotavirus in the 28 days after, or&#xD;
&#xD;
               -  another investigational vaccine or investigational drug in the 56 days after.&#xD;
&#xD;
          -  Any previous receipt of supplemental oxygen therapy in a home or hospital setting,&#xD;
             except the temporary receipt of supplemental oxygen for transient tachypnea in newborn&#xD;
&#xD;
          -  Member of a household that contains an immunocompromised individual, including, but&#xD;
             not limited to:&#xD;
&#xD;
               -  a person who is HIV infected&#xD;
&#xD;
               -  a person who has received chemotherapy within the 12 months prior to enrollment&#xD;
&#xD;
               -  a person receiving immunosuppressant agents&#xD;
&#xD;
               -  a person living with a solid organ or bone marrow transplant&#xD;
&#xD;
          -  Participation at the time of study enrollment (or in the 6 weeks preceding the first&#xD;
             trial vaccination) or planned participation during the present trial period in another&#xD;
             clinical trial investigating a vaccine, drug, medical device, or medical procedure&#xD;
&#xD;
          -  Member of a household that contains, or will contain, an infant who is less than 6&#xD;
             months of age at the enrollment date (or in the 6 weeks preceding the first trial&#xD;
             vaccination) through Day 28&#xD;
&#xD;
          -  Member of a household that contains another child/other children who is/are, or is/are&#xD;
             scheduled to be, enrolled in this study in the same year AND the date of enrollment&#xD;
             will not be concurrent with the other participant(s) living in the household (i.e.,&#xD;
             all eligible children from the same household must be enrolled on the same date)&#xD;
&#xD;
          -  Attends a daycare facility and shares a daycare room with infants less than 6 months&#xD;
             of age, and parent/guardian is unable or unwilling to suspend daycare for 28 days&#xD;
             following inoculation&#xD;
&#xD;
          -  Deprived of freedom in an emergency setting or hospitalized involuntarily&#xD;
&#xD;
          -  Identified as a natural or adopted child of the Investigator or employee with direct&#xD;
             involvement in the proposed study&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a&#xD;
        participant's potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>18 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi Pasteur, a Sanofi Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Matrix Clinical Research-Site Number:8400012</name>
      <address>
        <city>Gardena</city>
        <state>California</state>
        <zip>90247</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paradigm Clinical Research-Site Number:8400026</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Matrix Clinical Research-Site Number:8400032</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Research Foundation-Site Number:8400016</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123-1881</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Clinical Trials, Inc.-Site Number:8400001</name>
      <address>
        <city>Blackfoot</city>
        <state>Idaho</state>
        <zip>83221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leavitt Clinical Research-Site Number:8400036</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Snake River Research-Site Number:8400022</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The South Bend Clinic Center for Research-Site Number:8400024</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>46617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance for Multispeciality Research-Site Number:8400014</name>
      <address>
        <city>El Dorado</city>
        <state>Kansas</state>
        <zip>67042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMR - Newton-Site Number:8400002</name>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <zip>67114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michael W. Simon, MD, PSC-Site Number:8400013</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benchmark Research-Site Number:8400006</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nola Research Works-Site Number:8400017</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute-Site Number:8400053</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boeson Research-Site Number:8400011</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Be Well Clinical Studies-Site Number:8400054</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research - Norfolk-Site Number:8400005</name>
      <address>
        <city>Norfolk</city>
        <state>Nebraska</state>
        <zip>68701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedPharmics Inc-Site Number:8400040</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Carolina University/Brody Medical Sciences Building-Site Number:8400043</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Pediatric Research-Site Number:8400031</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tribe Clinical Research-Site Number:8400027</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FMC Science-Site Number:8400042</name>
      <address>
        <city>Lampasas</city>
        <state>Texas</state>
        <zip>76550-1820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JBR Clinical Research-Site Number:8400041</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Associates of Charlottesville North-Site Number:8400007</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Clinical Research Inc-Site Number:8400004</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1520001</name>
      <address>
        <city>Santiago</city>
        <state>Reg Metropolitana De Santiago</state>
        <zip>8380453</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1520004</name>
      <address>
        <city>Santiago</city>
        <state>Reg Metropolitana De Santiago</state>
        <zip>8420383</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3400002</name>
      <address>
        <city>Municipio Del Distrito Central</city>
        <zip>11101</zip>
        <country>Honduras</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3400001</name>
      <address>
        <city>San Pedro Sula</city>
        <zip>21104</zip>
        <country>Honduras</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
    <country>Honduras</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>May 16, 2023</last_update_submitted>
  <last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 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 Syncytial Virus Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04491877
org study id: VAD00001
secondary id: U1111-1238-1869
nct id: NCT04491877
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The primary objectives of the study are:

        -  To assess the safety profile of each dose of the study product after each and any
           administration in all infants and toddlers regardless of baseline serostatus.

        -  To characterize the Respiratory Syncytial Virus (RSV) A serum neutralizing antibody
           responses to the study product in each vaccine group after vaccination in RSV-naïve
           participants.

      The secondary objectives of the study are:

        -  To quantify the amount of vaccine virus shed by each participant by baseline serostatus.

        -  To determine the proportion of vaccinated infants and toddlers in each vaccine group
           infected with the vaccine virus at D56 (56 days after vaccination 1) for Cohorts 1, 2, 3
           and 4, and at Day 84 (28 days after vaccination 2) for Cohorts 2 and 4 by baseline
           serostatus.

        -  To characterize the RSV A serum neutralizing antibody responses to the study product in
           each vaccine group after vaccination in RSV-experienced participants.

        -  To characterize serum RSV anti-F immunoglobulin G (IgG) antibody responses to the study
           product in each vaccine group after vaccination by baseline serostatus.

        -  To characterize serum RSV antibody responses (RSV A-neutralizing and anti-RSV F IgG) to
           the study product in each vaccine group after the RSV surveillance season or at least 5
           months after the last vaccine administration by baseline serostatus.
Study duration per participant is maximum 12 months
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The study is performed in an observer-blind fashion. Investigators and study staff who conduct the safety assessment and the participants do not know which vaccine is administered. Only the study staff who prepare and administer the vaccine and are not involved with the safety evaluation knows which vaccine is administered.
measure: Number of participants reporting immediate adverse events
time frame: Within 30 minutes after vaccination
description: Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination.
measure: Number of participants reporting solicited reactions
time frame: Within 28 days after vaccination
description: Solicited administrative site reaction: rhinorrhea. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability.
measure: Number of participants reporting unsolicited adverse events
time frame: Within 28 days after vaccination
description: Unsolicited adverse events are spontaneously reported adverse events.
measure: Number of participants reporting adverse events of special interest
time frame: Within 28 days after vaccination
description: Adverse events of special interest pre-defined adverse event collected using the same process as for other adverse events.
measure: Number of participants reporting medically attended adverse events
time frame: Within 28 days after vaccination
description: Medically attended adverse events are adverse events with a new onset or a worsening of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department.
measure: Number of participants reporting serious adverse events
time frame: Day 0 to maximum Month 12
description: Serious adverse events are collected throughout the study, from Day 0 until the end of the study.
measure: RSV A serum neutralizing antibody levels after first vaccine administration
time frame: Day 56
description: RSV A serum neutralizing antibody levels assessed in RSV-naïve participants in Cohorts 1, 2, 3, and 4.
measure: RSV A serum neutralizing antibody levels after second vaccine administration
time frame: Day 84
description: RSV A serum neutralizing antibody levels are assessed in RS-naïve participants in Cohorts 2 and 4.
measure: Titer of vaccine virus shedding (polymerase chain reaction [RT-PCR])
time frame: 7 days after vaccination
description: Titers are assessed by PCR at Day 7 for Cohorts 1, 2, 3 and 4 and Day 63 for Cohorts 2 and 4.
measure: Number of participants infected with the vaccine virus
time frame: Day 56 and Day 84
description: Infection is defined as detection of vaccine in nasal wash by culture or PCR and / or a ≥ 4-fold rise in serum neutralizing antibodies or in serum antibodies to RSV F. Infectivity is assessed on Day 56 for Cohorts 1, 2, 3 and 4, and after vaccination 2 (Day 84) for Cohorts 2 and 4
measure: RSV A serum neutralizing antibody levels
time frame: Day 56 and Day 84
description: RSV serum neutralizing antibody levels assessed in RSV-experienced participants on Day 56 for Cohorts 1, 2, 3 and 4, and after vaccination 2 (Day 84) for Cohorts 2 and 4.
measure: RSV serum anti-F binding antibody levels
time frame: Day 56 and Day 84
description: RSV serum anti-F binding antibody levels assessed on Day 56 for Cohorts 1, 2, 3 and 4, and after vaccination 2 (Day 84) for Cohorts 2 and 4.
measure: RSV A serum neutralizing and serum anti-RSV F IgG antibody titers after the RSV surveillance season or at least 5 months after the last vaccine administration
time frame: Within 1 month after the end of the RSV season or at least 5 months after the last vaccine administration.
description: RSV A serum neutralizing and serum anti-RSV F IgG antibody titers are assessed after the end of the RSV season (on average end of March in the Northern Hemisphere and end of September in the Southern Hemisphere) or at least 5 months after the last vaccine administration.
arm group label: Cohort 1 (RSV vaccine formulation 1)
arm group type: Experimental
description: 1 administration of RSV vaccine formulation 1 on Day 0
arm group label: Cohort 1 (Placebo)
arm group type: Placebo Comparator
description: 1 administration of placebo on Day 0
arm group label: Cohort 2 (RSV vaccine formulation 1)
arm group type: Experimental
description: 2 administrations of RSV vaccine formulation 1 on Day 0 and Day 56
arm group label: Cohort 2 (Placebo)
arm group type: Placebo Comparator
description: 2 administrations of placebo on Day 0 and Day 56
arm group label: Cohort 3 (RSV vaccine formulation 2)
arm group type: Experimental
description: 1 administration of RSV vaccine formulation 2 on Day 0
arm group label: Cohort 3 (Placebo)
arm group type: Placebo Comparator
description: 1 administration of placebo on Day 0
arm group label: Cohort 4 (RSV vaccine formulation 1)
arm group type: Experimental
description: 2 administrations of RSV vaccine formulation 1 on Day 0 and Day 56
arm group label: Cohort 4 (RSV vaccine formulation 2)
arm group type: Experimental
description: 2 administrations of RSV vaccine formulation 2 on Day 0 and Day 56
arm group label: Cohort 4 (Placebo)
arm group type: Placebo Comparator
description: 2 administrations of placebo on Day 0 and Day 56
intervention type: Biological
intervention name: RSV vaccine formulation 1
description: Pharmaceutical form: Suspension of virus Route of administration: Intranasal
arm group label: Cohort 1 (RSV vaccine formulation 1)
arm group label: Cohort 2 (RSV vaccine formulation 1)
arm group label: Cohort 4 (RSV vaccine formulation 1)
intervention type: Biological
intervention name: RSV vaccine formulation 2
description: Pharmaceutical form: Suspension of virus Route of administration: Intranasal
arm group label: Cohort 3 (RSV vaccine formulation 2)
arm group label: Cohort 4 (RSV vaccine formulation 2)
intervention type: Biological
intervention name: Placebo
description: Pharmaceutical form: Suspension Route of administration: Intranasal
arm group label: Cohort 1 (Placebo)
arm group label: Cohort 2 (Placebo)
arm group label: Cohort 3 (Placebo)
arm group label: Cohort 4 (Placebo)
criteria: 
gender: All
minimum age: 6 Months
maximum age: 18 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi Pasteur, a Sanofi Company
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country: Chile
country: Honduras
country: United States
responsible party type: Sponsor
mesh term: Respiratory Syncytial Virus Infections
mesh term: Vaccines
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org