xml: <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/NCT05964582</url>
    </required_header>
    <id_info>
      <org_study_id>VAD00019</org_study_id>
      <secondary_id>U1111-1281-0204</secondary_id>
      <nct_id>NCT05964582</nct_id>
    </id_info>
    <brief_title>Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers</brief_title>
    <official_title>A Multi-center, Multi-national, Prospective Surveillance Study of Respiratory Syncytial Virus Disease in Infants and Toddlers 6 to &lt; 22 Months of Age</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>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study is a multi-center, multi-national, prospective surveillance study in which the&#xD;
        study participants will not receive a study vaccine but will provide a baseline blood sample&#xD;
        and be followed for acute respiratory disease during 6 months. The 6-month follow-up will&#xD;
        occur for the most part during the Respiratory Syncytial Virus(RSV) season (based on&#xD;
        enrollment timing and as per feasibility). A maximum of 1000 children from 6 to &lt; 22 months&#xD;
        of age are planned to be enrolled in 5 to 10 countries, 1 to 2 sites per country, targeting&#xD;
        approximately 100 participants per country. The purpose of the study is to assess the&#xD;
        seroprevalence and incidence of RSV disease during the study period in the targeted countries&#xD;
        and sites for a Phase III vaccine study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The duration of the study will be 6 months for each participant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">January 7, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 7, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>RSV A serum neutralizing antibody (Nab) titers</measure>
      <time_frame>At Day 1</time_frame>
      <description>To assess RSV A serum Nab titers overall</description>
    </primary_outcome>
    <primary_outcome>
      <measure>RSV A serum neutralizing antibody (Nab) titers</measure>
      <time_frame>At Day 1</time_frame>
      <description>To assess RSV A serum Nab titers by country</description>
    </primary_outcome>
    <primary_outcome>
      <measure>RSV B serum Nab titers</measure>
      <time_frame>At Day 1</time_frame>
      <description>To assess RSV B serum Nab titers overall</description>
    </primary_outcome>
    <primary_outcome>
      <measure>RSV B serum Nab titers</measure>
      <time_frame>At Day 1</time_frame>
      <description>To assess RSV B serum Nab titers overall by country</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Anti-F immunoglobulin A (IgA) and G (IgG) enzyme linked immunosorbant assay (ELISA) titers</measure>
      <time_frame>At Day 1</time_frame>
      <description>To assess Anti-F IgA and IgG ELISA titers overall</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Anti-F immunoglobulin A (IgA) and G (IgG) enzyme linked immunosorbant assay (ELISA) titers</measure>
      <time_frame>At Day 1</time_frame>
      <description>To assess Anti-F IgA and IgG ELISA titers by country</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Baseline serostatus</measure>
      <time_frame>At Day 1</time_frame>
      <description>To assess baseline serostatus overall</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Baseline serostatus</measure>
      <time_frame>At Day 1</time_frame>
      <description>To assess baseline serostatus by country</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study</measure>
      <time_frame>Throughout study, approximately 6 months</time_frame>
      <description>To assess to incidence of ARD confirmed by RT PCR overall</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study</measure>
      <time_frame>Throughout study, approximately 6 months</time_frame>
      <description>To assess to incidence of ARD confirmed by RT PCR by country</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study</measure>
      <time_frame>Throughout study, approximately 6 months</time_frame>
      <description>To assess to incidence of LRTD confirmed by RT PCR overall</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study</measure>
      <time_frame>Throughout study, approximately 6 months</time_frame>
      <description>To assess to incidence of LRTD confirmed by RT PCR by country</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>RSV A serum Nab titers</measure>
      <time_frame>At Day 1</time_frame>
      <description>To assess RSV A serum Nab titers for each age group overall</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>RSV A serum Nab titers</measure>
      <time_frame>At Day 1</time_frame>
      <description>To assess RSV A serum Nab titers for each age group by country</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>RSV B serum Nab antibody titers</measure>
      <time_frame>At Day 1</time_frame>
      <description>To assess RSV B serum Nab titers for each age group overall</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>RSV B serum Nab antibody titers</measure>
      <time_frame>At Day 1</time_frame>
      <description>To assess RSV B serum Nab titers for each age group by country</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anti-F IgA and IgG ELISA titers</measure>
      <time_frame>At Day 1</time_frame>
      <description>To assess Anti-F IgA and IgG ELISA titers for each age group overall</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anti-F IgA and IgG ELISA titers</measure>
      <time_frame>At Day 1</time_frame>
      <description>To assess Anti-F IgA and IgG ELISA titers for each age group by country</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Baseline serostatus by age group</measure>
      <time_frame>At Day 1</time_frame>
      <description>To assess baseline serostatus for each age group overall</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Baseline serostatus by age group</measure>
      <time_frame>At Day 1</time_frame>
      <description>To assess baseline serostatus for each age group by country</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study</measure>
      <time_frame>Throughout study, approximately 6 months</time_frame>
      <description>To assess to incidence of ARD confirmed by RT PCR for each age group overall</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study</measure>
      <time_frame>Throughout study, approximately 6 months</time_frame>
      <description>To assess to incidence of ARD confirmed by RT PCR for each age group by country</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study</measure>
      <time_frame>Throughout study, approximately 6 months</time_frame>
      <description>To assess to incidence of LRTD confirmed by RT PCR for each age group overall</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study</measure>
      <time_frame>Throughout study, approximately 6 months</time_frame>
      <description>To assess to incidence of LRTD confirmed by RT PCR for each age group by country</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of ARD associated with each RT-PCR confirmed RSV strain (A/B) during the study</measure>
      <time_frame>Throughout study, approximately 6 months</time_frame>
      <description>To assess to incidence of ARD confirmed by RT PCR for each strain overall</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of ARD associated with each RT-PCR confirmed RSV strain (A/B) during the study</measure>
      <time_frame>Throughout study, approximately 6 months</time_frame>
      <description>To assess to incidence of ARD confirmed by RT PCR for each strain by country</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of severe LRTD associated with any RT PCR confirmed RSV strain during the study</measure>
      <time_frame>Throughout study, approximately 6 months</time_frame>
      <description>To assess the severity of LRTD confirmed by any RT PCR for each strain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of LRTD associated with each RT-PCR confirmed RSV strain (A/B) during the study</measure>
      <time_frame>Throughout study, approximately 6 months</time_frame>
      <description>To assess to incidence of LRTD confirmed by RT PCR for each strain overall</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of LRTD associated with each RT-PCR confirmed RSV strain (A/B) during the study</measure>
      <time_frame>Throughout study, approximately 6 months</time_frame>
      <description>To assess to incidence of LRTD confirmed by RT PCR for each strain by country</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of clinically diagnosed RSV ARD according to routine practice (with or without RT-PCR RSV confirmation) during the study</measure>
      <time_frame>Throughout study, approximately 6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of clinically diagnosed RSV LRTD according to routine practice (with or without RT-PCR RSV confirmation) during the study</measure>
      <time_frame>Throughout study, approximately 6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of AOM episodes during the study</measure>
      <time_frame>Throughout study, approximately 6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of ARD and LRTD associated with any RT PCR confirmed RSV strain during the study, RSV A and RSV B serum neutralizing antibody titers, anti-F IgA and IgG ELISA antibody titers</measure>
      <time_frame>At Day 1</time_frame>
      <description>To assess the association between RT-PCR confirmed RSV ARD and LRTD and RSV A, B, anti-G IgA an IgG ELISA antibodies at baseline</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Respiratory Syncytial Virus Infections</condition>
    <arm_group>
      <arm_group_label>Healthy children aged 6 months to &lt; 22 months</arm_group_label>
      <description>No vaccine will be administered. All enrolled participants will have a blood sample collected at enrollment (visit 01) and a nasal swab collected each time they have an RSV-like illness visit</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy volunteers&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 6 months to &lt; 22 months on the day of inclusion (means the day of the 6-month&#xD;
               birthday to the day before the 22-month birthday)&#xD;
  &#xD;
            -  Participants who are healthy as determined by medical evaluation including medical&#xD;
               history&#xD;
  &#xD;
            -  Born at full term of pregnancy (≥ 37 weeks) or born after a gestation period of 27&#xD;
               through 36 weeks and medically stable as assessed by the investigator, based on the&#xD;
               following definition: &quot;Medically stable&quot; refers to the condition of premature infants&#xD;
               who do not require significant medical support or ongoing management for debilitating&#xD;
               disease and who have demonstrated a clinical course of sustained recovery by the time&#xD;
               they are enrolled in the study&#xD;
  &#xD;
          Exclusion Criteria:&#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;
            -  Chronic illness that, in the opinion of the investigator, is at a stage where it might&#xD;
               interfere with study conduct or completion&#xD;
  &#xD;
            -  Probable or confirmed ongoing case of viral respiratory infection (including COVID-19,&#xD;
               influenza, rhinovirus, etc.) at the time of enrollment. A prospective participant&#xD;
               should not be included in the study until the respiratory infection has resolved&#xD;
  &#xD;
            -  Member of a household that contains an immunocompromised individual, including, but&#xD;
               not limited to:&#xD;
  &#xD;
                 -  a person who is human immunodeficiency virus (HIV) infected&#xD;
  &#xD;
                 -  a person who has received chemotherapy within the 12 months prior to study&#xD;
                    enrollment&#xD;
  &#xD;
                 -  a person who has received (within the past 6 months) or is receiving (at the time&#xD;
                    of enrollment) immunosuppressant agents&#xD;
  &#xD;
                 -  a person living with a solid organ or bone marrow transplant&#xD;
  &#xD;
            -  Participant's mother previous receipt or planned administration of an investigational&#xD;
               RSV vaccine during pregnancy and/or breastfeeding&#xD;
  &#xD;
            -  Receipt or planned receipt of any of the following vaccines:&#xD;
  &#xD;
                 -  Any intranasal live attenuated vaccine within the 28 days prior to enrollment&#xD;
  &#xD;
                 -  Any injectable live attenuated vaccine within the 28 days prior to and after&#xD;
                    enrollment&#xD;
  &#xD;
            -  Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product&#xD;
               (such as ribavirin or RSV immune globulin or RSV monoclonal antibody) less than 6&#xD;
               months before enrollment&#xD;
  &#xD;
            -  Receipt of immune globulins, blood or blood-derived products in the past 3 months&#xD;
  &#xD;
            -  Participation at the time of study enrollment or planned participation during the&#xD;
               present study period in another clinical study investigating a vaccine, drug, medical&#xD;
               device, or medical procedure&#xD;
  &#xD;
          The above information is not intended to contain all considerations relevant to a patient's&#xD;
          potential participation in a clinical trial&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Months</minimum_age>
      <maximum_age>21 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Clinical Sciences &amp;amp; Operations</last_name>
      <role>Study Director</role>
      <affiliation>Sanofi</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Trial Transparency email recommended (Toll free for US &amp;amp; Canada)</last_name>
      <phone>800-633-1610</phone>
      <phone_ext>option 6</phone_ext>
      <email>Contact-US@sanofi.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 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>Virus Diseases</mesh_term>
      <mesh_term>Respiratory Syncytial Virus Infections</mesh_term>
    </condition_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>
  
  
text: 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/NCT05964582
  org study id: VAD00019
  secondary id: U1111-1281-0204
  nct id: NCT05964582
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study is a multi-center, multi-national, prospective surveillance study in which the
        study participants will not receive a study vaccine but will provide a baseline blood sample
        and be followed for acute respiratory disease during 6 months. The 6-month follow-up will
        occur for the most part during the Respiratory Syncytial Virus(RSV) season (based on
        enrollment timing and as per feasibility). A maximum of 1000 children from 6 to < 22 months
        of age are planned to be enrolled in 5 to 10 countries, 1 to 2 sites per country, targeting
        approximately 100 participants per country. The purpose of the study is to assess the
        seroprevalence and incidence of RSV disease during the study period in the targeted countries
        and sites for a Phase III vaccine study.
  The duration of the study will be 6 months for each participant.
  observational model: Other
  time perspective: Prospective
  measure: RSV A serum neutralizing antibody (Nab) titers
  time frame: At Day 1
  description: To assess RSV A serum Nab titers overall
  measure: RSV A serum neutralizing antibody (Nab) titers
  time frame: At Day 1
  description: To assess RSV A serum Nab titers by country
  measure: RSV B serum Nab titers
  time frame: At Day 1
  description: To assess RSV B serum Nab titers overall
  measure: RSV B serum Nab titers
  time frame: At Day 1
  description: To assess RSV B serum Nab titers overall by country
  measure: Anti-F immunoglobulin A (IgA) and G (IgG) enzyme linked immunosorbant assay (ELISA) titers
  time frame: At Day 1
  description: To assess Anti-F IgA and IgG ELISA titers overall
  measure: Anti-F immunoglobulin A (IgA) and G (IgG) enzyme linked immunosorbant assay (ELISA) titers
  time frame: At Day 1
  description: To assess Anti-F IgA and IgG ELISA titers by country
  measure: Baseline serostatus
  time frame: At Day 1
  description: To assess baseline serostatus overall
  measure: Baseline serostatus
  time frame: At Day 1
  description: To assess baseline serostatus by country
  measure: Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
  time frame: Throughout study, approximately 6 months
  description: To assess to incidence of ARD confirmed by RT PCR overall
  measure: Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
  time frame: Throughout study, approximately 6 months
  description: To assess to incidence of ARD confirmed by RT PCR by country
  measure: Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
  time frame: Throughout study, approximately 6 months
  description: To assess to incidence of LRTD confirmed by RT PCR overall
  measure: Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
  time frame: Throughout study, approximately 6 months
  description: To assess to incidence of LRTD confirmed by RT PCR by country
  measure: RSV A serum Nab titers
  time frame: At Day 1
  description: To assess RSV A serum Nab titers for each age group overall
  measure: RSV A serum Nab titers
  time frame: At Day 1
  description: To assess RSV A serum Nab titers for each age group by country
  measure: RSV B serum Nab antibody titers
  time frame: At Day 1
  description: To assess RSV B serum Nab titers for each age group overall
  measure: RSV B serum Nab antibody titers
  time frame: At Day 1
  description: To assess RSV B serum Nab titers for each age group by country
  measure: Anti-F IgA and IgG ELISA titers
  time frame: At Day 1
  description: To assess Anti-F IgA and IgG ELISA titers for each age group overall
  measure: Anti-F IgA and IgG ELISA titers
  time frame: At Day 1
  description: To assess Anti-F IgA and IgG ELISA titers for each age group by country
  measure: Baseline serostatus by age group
  time frame: At Day 1
  description: To assess baseline serostatus for each age group overall
  measure: Baseline serostatus by age group
  time frame: At Day 1
  description: To assess baseline serostatus for each age group by country
  measure: Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
  time frame: Throughout study, approximately 6 months
  description: To assess to incidence of ARD confirmed by RT PCR for each age group overall
  measure: Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
  time frame: Throughout study, approximately 6 months
  description: To assess to incidence of ARD confirmed by RT PCR for each age group by country
  measure: Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
  time frame: Throughout study, approximately 6 months
  description: To assess to incidence of LRTD confirmed by RT PCR for each age group overall
  measure: Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
  time frame: Throughout study, approximately 6 months
  description: To assess to incidence of LRTD confirmed by RT PCR for each age group by country
  measure: Occurrence of ARD associated with each RT-PCR confirmed RSV strain (A/B) during the study
  time frame: Throughout study, approximately 6 months
  description: To assess to incidence of ARD confirmed by RT PCR for each strain overall
  measure: Occurrence of ARD associated with each RT-PCR confirmed RSV strain (A/B) during the study
  time frame: Throughout study, approximately 6 months
  description: To assess to incidence of ARD confirmed by RT PCR for each strain by country
  measure: Occurrence of severe LRTD associated with any RT PCR confirmed RSV strain during the study
  time frame: Throughout study, approximately 6 months
  description: To assess the severity of LRTD confirmed by any RT PCR for each strain
  measure: Occurrence of LRTD associated with each RT-PCR confirmed RSV strain (A/B) during the study
  time frame: Throughout study, approximately 6 months
  description: To assess to incidence of LRTD confirmed by RT PCR for each strain overall
  measure: Occurrence of LRTD associated with each RT-PCR confirmed RSV strain (A/B) during the study
  time frame: Throughout study, approximately 6 months
  description: To assess to incidence of LRTD confirmed by RT PCR for each strain by country
  measure: Occurrence of clinically diagnosed RSV ARD according to routine practice (with or without RT-PCR RSV confirmation) during the study
  time frame: Throughout study, approximately 6 months
  measure: Occurrence of clinically diagnosed RSV LRTD according to routine practice (with or without RT-PCR RSV confirmation) during the study
  time frame: Throughout study, approximately 6 months
  measure: Occurrence of AOM episodes during the study
  time frame: Throughout study, approximately 6 months
  measure: Occurrence of ARD and LRTD associated with any RT PCR confirmed RSV strain during the study, RSV A and RSV B serum neutralizing antibody titers, anti-F IgA and IgG ELISA antibody titers
  time frame: At Day 1
  description: To assess the association between RT-PCR confirmed RSV ARD and LRTD and RSV A, B, anti-G IgA an IgG ELISA antibodies at baseline
  arm group label: Healthy children aged 6 months to < 22 months
  description: No vaccine will be administered. All enrolled participants will have a blood sample collected at enrollment (visit 01) and a nasal swab collected each time they have an RSV-like illness visit
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 6 Months
  maximum age: 21 Months
  healthy volunteers: Accepts Healthy Volunteers
  last name: Clinical Sciences &amp; Operations
  role: Study Director
  affiliation: Sanofi
  last name: Trial Transparency email recommended (Toll free for US &amp; Canada)
  phone: 800-633-1610
  phone ext: option 6
  email: Contact-US@sanofi.com
  responsible party type: Sponsor
  mesh term: Virus Diseases
  mesh term: Respiratory Syncytial Virus Infections
  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