<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/NCT03227029</url>
  </required_header>
  <id_info>
    <org_study_id>IMPAACT 2018</org_study_id>
    <secondary_id>38405</secondary_id>
    <nct_id>NCT03227029</nct_id>
    <nct_alias>NCT03422237</nct_alias>
  </id_info>
  <brief_title>Evaluating the Infectivity, Safety, and Immunogenicity of Recombinant Live-Attenuated RSV Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants 6 to 24 Months of Age</brief_title>
  <official_title>Randomized Phase I Study of the Infectivity, Safety, and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the infectivity, safety, and immunogenicity of the&#xD;
      recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L&#xD;
      or RSV 276 when delivered as nose drops to RSV-seronegative infants 6 to 24 months of age.&#xD;
&#xD;
      This study was a companion study to Center for Immunization Research (CIR) 321.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Human respiratory syncytial virus (RSV) is the most common viral cause of serious acute lower&#xD;
      respiratory illness (LRI) in infants and children under 5 years of age worldwide. This study&#xD;
      evaluated the infectivity, safety, and immunogenicity of two recombinant live-attenuated RSV&#xD;
      vaccines: RSV ΔNS2/Δ1313/I1314L and RSV 276. The vaccines were delivered as nose drops to&#xD;
      RSV-seronegative infants 6 to 24 months of age.&#xD;
&#xD;
      Participants were randomly assigned to receive a single dose of the RSV ΔNS2/Δ1313/I1314L&#xD;
      vaccine, the RSV 276 vaccine, or placebo at study entry (Day 0).&#xD;
&#xD;
      Participants could be enrolled in the study outside of RSV season, i.e., between April 1 and&#xD;
      October 14 for most sites or-for sites with local RSV seasons that start earlier-as specified&#xD;
      on a site-by-site basis in the manual of procedures. Participants remained on study until&#xD;
      they completed the post-RSV season visit between April 1 and April 30 in the calendar year&#xD;
      following enrollment. Participants' total study duration was between 6 and 13 months,&#xD;
      depending on when they enrolled in the study. Participants attended several study visits&#xD;
      throughout the study, which included physical examinations, blood collection, nasal washes,&#xD;
      and/or nasal adsorption (nasosorption) specimen collection. Participants' parents or&#xD;
      guardians were contacted by study staff at various times during the study to monitor&#xD;
      participants' health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 22, 2017</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 19, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Solicited Adverse Events (AEs) by Grade</measure>
    <time_frame>Measured from Day 0 through Day 28</time_frame>
    <description>Solicited adverse events included fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI). The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 5 and Table 6 in the protocol document.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Unsolicited AEs</measure>
    <time_frame>Measured from Day 0 through Day 28</time_frame>
    <description>Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each unsolicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. AE grading (Grade 1- mild to Grade 4-life-threatening) was done by Division of AIDS (DAIDS) AE Grading table v2.0 (see References).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Serious Adverse Events (SAEs)</measure>
    <time_frame>Measured from Day 0 through Day 56</time_frame>
    <description>A Serious Adverse Event (SAE) is an AE, whether considered related to the study product or not, that:&#xD;
Results in death during the period of protocol-defined surveillance;&#xD;
Is life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death were it more severe;&#xD;
Requires inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting;&#xD;
Results in a persistent or significant disability/incapacity;&#xD;
Is a congenital anomaly or birth defect, OR&#xD;
Is an important medical event that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Infected With RSV Vaccine Virus</measure>
    <time_frame>Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28 for nasal washes, and at Days 0, 56 for serum RSV-neutralizing antibodies</time_frame>
    <description>Defined as 1) vaccine virus identified in a nasal wash from Study Day 0-28 (a binary outcome based on nasal washes); and/or 2) greater than or equal to 4-fold rise in RSV serum neutralizing antibody titer and/or serum enzyme-linked immunosorbent assay (ELISA) titer to the RSV F protein from study entry to Study Day 56</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak Titer of Vaccine Virus Shed</measure>
    <time_frame>Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28</time_frame>
    <description>This is the highest value per participant of the titer of vaccine virus shed. It was measured by culture. Only participants who met the definition of infection with vaccine virus were included.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of Virus Shedding in Nasal Washes</measure>
    <time_frame>Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28. Last day positive is reported.</time_frame>
    <description>Determined separately by a) culture and b) reverse transcription polymerase chain reaction (RT-PCR)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titers</measure>
    <time_frame>Measured at Day 0 and Day 56</time_frame>
    <description>Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum RSV-neutralizing Antibody Titers</measure>
    <time_frame>Measured at Day 56</time_frame>
    <description>Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum Antibody Titers to RSV F Glycoprotein</measure>
    <time_frame>Measured at Day 0 and Day 56</time_frame>
    <description>Antibodies were assessed by Enzyme-linked Immunosorbent Assay (ELISA). A response was defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Antibody Responses to RSV F Glycoprotein</measure>
    <time_frame>Measured at Day 56</time_frame>
    <description>Serum antibody titers to RSV F glycoprotein were assessed by ELISA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Had RSV-associated Symptomatic, Medically Attended Respiratory and Febrile Illness, by Grade, Among Those Who Experienced Natural Infection With wt RSV During the Subsequent RSV Season</measure>
    <time_frame>Measured through participant's last study visit, up to a total of 6 to 10 months depending on when participants enrolled in the study</time_frame>
    <description>The number of participants who had RSV-associated, symptomatic, medically attended respiratory and febrile illness (MAARI) among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal washes collected during illness visits for MAARI events or a &gt; 4-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events. A participant was only counted once in each MAARI category, and that was in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 5 and Table 6 in the protocol document.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnitude of Serum RSV-neutralizing Antibody Responses in the Vaccine and Placebo Recipients Who Experienced Natural Infection With wt RSV During the Subsequent RSV Season.</measure>
    <time_frame>Measured through participant's last study visit, up to a total of 6 to 10 months depending on when participants enrolled in the study</time_frame>
    <description>Only participants who had RSV detected in nasal washes or a greater than or equal to 4-fold rise in serum antibodies during the subsequent RSV season were included. RSV-neutralizing antibody titers were measured pre- and post-RSV surveillance season subsequent to the time of the inoculation.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Respiratory Syncytial Virus Infections</condition>
  <arm_group>
    <arm_group_label>RSV ΔNS2/Δ1313/I1314L vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RSV 276 vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received a single dose of placebo at study entry (Day 0).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>RSV ΔNS2/Δ1313/I1314L</intervention_name>
    <description>10^6 plaque-forming units (PFU); administered as nose drops</description>
    <arm_group_label>RSV ΔNS2/Δ1313/I1314L vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>RSV 276</intervention_name>
    <description>10^5 PFU; administered as nose drops</description>
    <arm_group_label>RSV 276 vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Isotonic diluent, administered as nose drops</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In good health based on review of the medical record, history, and physical&#xD;
             examination, without evidence of chronic disease.&#xD;
&#xD;
          -  Parent/guardian willing and able to provide written informed consent as described in&#xD;
             the protocol.&#xD;
&#xD;
          -  Seronegative for RSV antibody, defined as a serum RSV-neutralizing antibody titer less&#xD;
             than 1:40 at screening from a sample collected no more than 42 days prior to&#xD;
             inoculation.&#xD;
&#xD;
          -  Growing normally for age (i.e., not downwardly crossing two major centiles on a&#xD;
             standard growth chart) in the six months prior to enrollment AND&#xD;
&#xD;
               -  If less than 1 year of age: current height and weight above the 5th percentile&#xD;
&#xD;
               -  If 1 year of age or older: current height and weight above the 3rd percentile for&#xD;
                  age.&#xD;
&#xD;
          -  Received routine immunizations appropriate for age (as per national Center for Disease&#xD;
             Control Advisory Committee on Immunization Practices).&#xD;
&#xD;
          -  Expected to be available for the duration of the study.&#xD;
&#xD;
          -  If born to an HIV-infected woman, participant must not have been breastfed and must&#xD;
             have documentation of 2 negative HIV nucleic acid (RNA or DNA) test results from&#xD;
             samples collected on different dates with both collected when greater than or equal to&#xD;
             4 weeks of age and at least one collected when greater than or equal to 16 weeks of&#xD;
             age, and no positive HIV nucleic acid (RNA or DNA) test; or 2 negative HIV antibody&#xD;
             tests, both from samples collected at greater than or equal to 24 weeks of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected HIV infection or impairment of immunological functions.&#xD;
&#xD;
          -  Receipt of immunosuppressive therapy, including any systemic, including either nasal&#xD;
             or inhaled, corticosteroids within 28 days of enrollment. Note: Cutaneous (topical)&#xD;
             steroid treatment is not an exclusion.&#xD;
&#xD;
          -  Any receipt of bone marrow/solid organ transplant.&#xD;
&#xD;
          -  Major congenital malformations (such as congenital cleft palate) or cytogenetic&#xD;
             abnormalities.&#xD;
&#xD;
          -  Previous receipt of a licensed or investigational RSV vaccine (or placebo in any&#xD;
             International Maternal Pediatric Adolescent AIDS Clinical Trials Network RSV study) or&#xD;
             previous receipt of or planned administration of any anti-RSV product (such as&#xD;
             ribavirin or RSV IG or RSV mAb).&#xD;
&#xD;
          -  Any previous anaphylactic reaction.&#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;
          -  Any known hypersensitivity to any study product component.&#xD;
&#xD;
          -  Heart disease. Note: Participants with cardiac abnormalities documented to be&#xD;
             clinically insignificant and requiring no treatment may be enrolled.&#xD;
&#xD;
          -  Lung disease, including any history of reactive airway disease or medically diagnosed&#xD;
             wheezing.&#xD;
&#xD;
          -  Member of a household that contained, or would contain, an infant who is less than 6&#xD;
             months of age at the enrollment date through Day 28.&#xD;
&#xD;
          -  Member of a household that contained another child/other children who was/were, or&#xD;
             was/were scheduled to be, enrolled in IMPAACT 2018 AND the date of enrollment to&#xD;
             IMPAACT 2018 would not be concurrent with the other participant(s) living in the&#xD;
             household (i.e., all eligible children from the same household must be enrolled on the&#xD;
             same date).&#xD;
&#xD;
          -  Member of a household that contained another child who was, or was scheduled to be,&#xD;
             enrolled in another study evaluating an intranasal live-attenuated RSV vaccine, AND&#xD;
             there has been or would be an overlap in residency during that other child's&#xD;
             participation in the study's Acute Phase (Days 0 to 28).&#xD;
&#xD;
          -  Member of a household that contained an immunocompromised individual, including, but&#xD;
             not limited to:&#xD;
&#xD;
               -  a person who was greater than or equal to 6 years of age with HIV-related&#xD;
                  immunodeficiency, defined as having a most recent CD4 T lymphocyte cell count&#xD;
                  less than 300 cells/mm^3. CD4 T lymphocyte count must have been measured within 6&#xD;
                  months prior to enrollment for individuals with detectable virus or within 12&#xD;
                  months prior to enrollment for individuals with undetectable virus, or&#xD;
&#xD;
               -  a person age 1 year up to less than 6 years with HIV-related immunodeficiency,&#xD;
                  defined as having a most recent CD4 T lymphocyte cell percentage less than 25 or&#xD;
                  CD4 T lymphocyte count less than 750 cells/mm^3 (if both values are available,&#xD;
                  use the lower of the two). CD4 T lymphocyte parameter must have been measured&#xD;
                  within the 6 months prior to enrollment; or&#xD;
&#xD;
               -  a person age less than 1 year with HIV-related immunodeficiency, defined as&#xD;
                  having a most recent CD4 T lymphocyte cell percentage less than 30 or CD4 T&#xD;
                  lymphocyte count less than 1000 cells/mm^3 (if both values are available, use the&#xD;
                  lower of the two). CD4 T lymphocyte parameter must have been measured within the&#xD;
                  6 months prior to enrollment; or&#xD;
&#xD;
               -  a person who had received chemotherapy within the 12 months prior to enrollment;&#xD;
                  or&#xD;
&#xD;
               -  a person receiving immunosuppressant agents; or&#xD;
&#xD;
               -  a person living with a solid organ or bone marrow transplant. Documenting the&#xD;
                  verbal report of CD4 T cell lymphocyte count was sufficient if the&#xD;
                  parent/guardian was confident of history. Individually identifiable information&#xD;
                  (e.g., name) pertaining to members of the household were not collected or&#xD;
                  recorded. Confirmatory laboratory tests for members of the household were not&#xD;
                  ordered or collected.&#xD;
&#xD;
          -  Attended a daycare facility and shared a room with infants less than 6 months of age,&#xD;
             and parent/guardian was unable or unwilling to suspend daycare for 28 days following&#xD;
             inoculation.&#xD;
&#xD;
          -  Any of the following events at the time of enrollment:&#xD;
&#xD;
               -  fever (rectal temperature of greater than or equal to 100.4°F (38°C)), or&#xD;
&#xD;
               -  upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis) or&#xD;
&#xD;
               -  nasal congestion significant enough to interfere with successful inoculation, or&#xD;
&#xD;
               -  otitis media.&#xD;
&#xD;
          -  Receipt of the following prior to enrollment:&#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;
          -  Scheduled administration of the following after planned inoculation:&#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;
          -  Receipt of immunoglobulin, any antibody products, or any blood products within the&#xD;
             past 6 months prior to enrollment.&#xD;
&#xD;
          -  Receipt of any of the following medications within 3 days prior to study enrollment:&#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 listed below. Permitted concomitant&#xD;
                  medications (prescription or non-prescription) include nutritional supplements,&#xD;
                  medications for gastroesophageal reflux, eye drops, and topical medications,&#xD;
                  including (but not limited to) cutaneous (topical) steroids, topical antibiotics,&#xD;
                  and topical antifungal agents.&#xD;
&#xD;
          -  Receipt of salicylate (aspirin) or salicylate-containing products within the 28 days&#xD;
             prior to enrollment.&#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 of&#xD;
             enrollment.&#xD;
&#xD;
          -  Current suspected or documented developmental disorder, delay, or other developmental&#xD;
             problem.&#xD;
&#xD;
          -  Any previous receipt of supplemental oxygen therapy in a home setting.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Coleen Cunningham, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Children's Health Center, DUMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093-0672</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Usc La Nichd Crs</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90089</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>David Geffen School of Medicine at UCLA NICHD CRS</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095-1752</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. of Colorado Denver NICHD CRS</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush Univ. Cook County Hosp. Chicago NICHD CRS</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lurie Children's Hospital of Chicago (LCH) CRS</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60614-3393</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University Center for Immunization Research</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center Ped. HIV Program NICHD CRS</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jacobi Med. Ctr. Bronx NICHD CRS</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUNY Stony Brook NICHD CRS</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Jude Children's Research Hospital CRS</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105-3678</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital CRS</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030-2399</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf</url>
    <description>Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017)</description>
  </link>
  <link>
    <url>http://rsc.niaid.nih.gov/clinical-research-sites/manual-expedited-reporting-adverse-events-daids</url>
    <description>Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010</description>
  </link>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <results_first_submitted>December 14, 2020</results_first_submitted>
  <results_first_submitted_qc>December 14, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 8, 2021</results_first_posted>
  <last_update_submitted>April 20, 2022</last_update_submitted>
  <last_update_submitted_qc>April 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2022</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>
  <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>June 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT03227029/Prot_002.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>September 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT03227029/SAP_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT03227029/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment period was from September 2017 to October 2019. Participants were recruited from 12 medical clinics all in the United States.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>RSV ΔNS2/Δ1313/I1314L Vaccine</title>
          <description>Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).&#xD;
RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops</description>
        </group>
        <group group_id="P2">
          <title>RSV 276 Vaccine</title>
          <description>Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).&#xD;
RSV 276: 10^5 PFU; administered as nose drops</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Participants received a single dose of placebo at study entry (Day 0).&#xD;
Placebo: Isotonic diluent, administered as nose drops</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Inoculation</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Child Wheezed (no treatment)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No post RSV season visit due to COVID</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not able to get to clinic</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to receive treatment in time (no treatment)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline analysis population was participants who received inoculation and were followed on study past Day 0.</population>
      <group_list>
        <group group_id="B1">
          <title>RSV ΔNS2/Δ1313/I1314L Vaccine</title>
          <description>Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).&#xD;
RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops</description>
        </group>
        <group group_id="B2">
          <title>RSV 276 Vaccine</title>
          <description>Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).&#xD;
RSV 276: 10^5 PFU; administered as nose drops</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Participants received a single dose of placebo at study entry (Day 0).&#xD;
Placebo: Isotonic diluent, administered as nose drops</description>
        </group>
        <group group_id="B4">
          <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="25"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="12"/>
            <count group_id="B4" value="62"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13" lower_limit="7" upper_limit="14"/>
                    <measurement group_id="B2" value="14" lower_limit="10" upper_limit="16"/>
                    <measurement group_id="B3" value="9" lower_limit="7.5" upper_limit="14.5"/>
                    <measurement group_id="B4" value="12.5" lower_limit="8" upper_limit="15"/>
                  </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="13"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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="1"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum RSV-neutralizing antibody titers</title>
          <units>Log 2 titers</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.3" lower_limit="2.3" upper_limit="3.3"/>
                    <measurement group_id="B2" value="2.3" lower_limit="2.3" upper_limit="2.3"/>
                    <measurement group_id="B3" value="2.3" lower_limit="2.3" upper_limit="2.9"/>
                    <measurement group_id="B4" value="2.3" lower_limit="2.3" upper_limit="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Adverse Events (AEs) by Grade</title>
        <description>Solicited adverse events included fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI). The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 5 and Table 6 in the protocol document.</description>
        <time_frame>Measured from Day 0 through Day 28</time_frame>
        <population>Study participants who received inoculation and were followed on study past Day 0 were included.</population>
        <group_list>
          <group group_id="O1">
            <title>RSV ΔNS2/Δ1313/I1314L Vaccine</title>
            <description>Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).&#xD;
RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops</description>
          </group>
          <group group_id="O2">
            <title>RSV 276 Vaccine</title>
            <description>Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).&#xD;
RSV 276: 10^5 PFU; administered as nose drops</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo at study entry (Day 0).&#xD;
Placebo: Isotonic diluent, administered as nose drops</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Adverse Events (AEs) by Grade</title>
          <description>Solicited adverse events included fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI). The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 5 and Table 6 in the protocol document.</description>
          <population>Study participants who received inoculation and were followed on study past Day 0 were included.</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="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fever</title>
              <category_list>
                <category>
                  <title>Did not have this AE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Otitis Media</title>
              <category_list>
                <category>
                  <title>Did not have this AE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper Respiratory Illness (URI)</title>
              <category_list>
                <category>
                  <title>Did not have this AE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lower Respiratory Illness (LRI) with RSV shedding</title>
              <category_list>
                <category>
                  <title>Did not have this AE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LRI in the absence of RSV shedding</title>
              <category_list>
                <category>
                  <title>Did not have this AE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cough, without LRI</title>
              <category_list>
                <category>
                  <title>Did not have this AE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>% vaccine recipients with solicited AEs</param_type>
            <param_value>64</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>46</ci_lower_limit>
            <ci_upper_limit>80</ci_upper_limit>
            <estimate_desc>Proportions of study participants were calculated and presented with 90% exact confidence intervals. This highlights that we are 95% sure that the true proportion is not higher that the upper limit of the confidence interval.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>% vaccine recipients with solicited AEs</param_type>
            <param_value>84</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>67</ci_lower_limit>
            <ci_upper_limit>94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>% placebo recipients with solicited AEs</param_type>
            <param_value>58</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>32</ci_lower_limit>
            <ci_upper_limit>82</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Unsolicited AEs</title>
        <description>Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each unsolicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. AE grading (Grade 1- mild to Grade 4-life-threatening) was done by Division of AIDS (DAIDS) AE Grading table v2.0 (see References).</description>
        <time_frame>Measured from Day 0 through Day 28</time_frame>
        <population>Study participants who received inoculation and were followed on study past Day 0 were included.</population>
        <group_list>
          <group group_id="O1">
            <title>RSV ΔNS2/Δ1313/I1314L Vaccine</title>
            <description>Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).&#xD;
RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops</description>
          </group>
          <group group_id="O2">
            <title>RSV 276 Vaccine</title>
            <description>Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).&#xD;
RSV 276: 10^5 PFU; administered as nose drops</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo at study entry (Day 0).&#xD;
Placebo: Isotonic diluent, administered as nose drops</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unsolicited AEs</title>
          <description>Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each unsolicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. AE grading (Grade 1- mild to Grade 4-life-threatening) was done by Division of AIDS (DAIDS) AE Grading table v2.0 (see References).</description>
          <population>Study participants who received inoculation and were followed on study past Day 0 were included.</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="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>% vaccine recipients with usolicited AEs</param_type>
            <param_value>36</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>20</ci_lower_limit>
            <ci_upper_limit>54</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>% vaccine recipients with usolicited AEs</param_type>
            <param_value>52</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>34</ci_lower_limit>
            <ci_upper_limit>69</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>% placebo recipients with usolicited AEs</param_type>
            <param_value>42</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>18</ci_lower_limit>
            <ci_upper_limit>68</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Serious Adverse Events (SAEs)</title>
        <description>A Serious Adverse Event (SAE) is an AE, whether considered related to the study product or not, that:&#xD;
Results in death during the period of protocol-defined surveillance;&#xD;
Is life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death were it more severe;&#xD;
Requires inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting;&#xD;
Results in a persistent or significant disability/incapacity;&#xD;
Is a congenital anomaly or birth defect, OR&#xD;
Is an important medical event that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.</description>
        <time_frame>Measured from Day 0 through Day 56</time_frame>
        <population>Study participants who received inoculation and were followed on study past Day 0 were included.</population>
        <group_list>
          <group group_id="O1">
            <title>RSV ΔNS2/Δ1313/I1314L Vaccine</title>
            <description>Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).&#xD;
RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops</description>
          </group>
          <group group_id="O2">
            <title>RSV 276 Vaccine</title>
            <description>Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).&#xD;
RSV 276: 10^5 PFU; administered as nose drops</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo at study entry (Day 0).&#xD;
Placebo: Isotonic diluent, administered as nose drops</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events (SAEs)</title>
          <description>A Serious Adverse Event (SAE) is an AE, whether considered related to the study product or not, that:&#xD;
Results in death during the period of protocol-defined surveillance;&#xD;
Is life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death were it more severe;&#xD;
Requires inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting;&#xD;
Results in a persistent or significant disability/incapacity;&#xD;
Is a congenital anomaly or birth defect, OR&#xD;
Is an important medical event that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.</description>
          <population>Study participants who received inoculation and were followed on study past Day 0 were included.</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="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" 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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Infected With RSV Vaccine Virus</title>
        <description>Defined as 1) vaccine virus identified in a nasal wash from Study Day 0-28 (a binary outcome based on nasal washes); and/or 2) greater than or equal to 4-fold rise in RSV serum neutralizing antibody titer and/or serum enzyme-linked immunosorbent assay (ELISA) titer to the RSV F protein from study entry to Study Day 56</description>
        <time_frame>Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28 for nasal washes, and at Days 0, 56 for serum RSV-neutralizing antibodies</time_frame>
        <population>Study participants who received inoculation and were followed on study past Day 0 were included. One child from a set of twins was randomly selected and excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>RSV ΔNS2/Δ1313/I1314L Vaccine</title>
            <description>Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).&#xD;
RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops</description>
          </group>
          <group group_id="O2">
            <title>RSV 276 Vaccine</title>
            <description>Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).&#xD;
RSV 276: 10^5 PFU; administered as nose drops</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo at study entry (Day 0).&#xD;
Placebo: Isotonic diluent, administered as nose drops</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Infected With RSV Vaccine Virus</title>
          <description>Defined as 1) vaccine virus identified in a nasal wash from Study Day 0-28 (a binary outcome based on nasal washes); and/or 2) greater than or equal to 4-fold rise in RSV serum neutralizing antibody titer and/or serum enzyme-linked immunosorbent assay (ELISA) titer to the RSV F protein from study entry to Study Day 56</description>
          <population>Study participants who received inoculation and were followed on study past Day 0 were included. One child from a set of twins was randomly selected and excluded from the analysis.</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="25"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>% recipients infected with vaccine virus</param_type>
            <param_value>88</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>72</ci_lower_limit>
            <ci_upper_limit>97</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>% recipients infected with vaccine virus</param_type>
            <param_value>96</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>82</ci_lower_limit>
            <ci_upper_limit>100</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>% recipients infected with vaccine virus</param_type>
            <param_value>0</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0</ci_lower_limit>
            <ci_upper_limit>22</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Peak Titer of Vaccine Virus Shed</title>
        <description>This is the highest value per participant of the titer of vaccine virus shed. It was measured by culture. Only participants who met the definition of infection with vaccine virus were included.</description>
        <time_frame>Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28</time_frame>
        <population>Only participants who met the definition of infection with vaccine virus were included.</population>
        <group_list>
          <group group_id="O1">
            <title>RSV ΔNS2/Δ1313/I1314L Vaccine</title>
            <description>Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).&#xD;
RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops</description>
          </group>
          <group group_id="O2">
            <title>RSV 276 Vaccine</title>
            <description>Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).&#xD;
RSV 276: 10^5 PFU; administered as nose drops</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo at study entry (Day 0).&#xD;
Placebo: Isotonic diluent, administered as nose drops</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Titer of Vaccine Virus Shed</title>
          <description>This is the highest value per participant of the titer of vaccine virus shed. It was measured by culture. Only participants who met the definition of infection with vaccine virus were included.</description>
          <population>Only participants who met the definition of infection with vaccine virus were included.</population>
          <units>log 10 PFU/mL</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="22"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="1.8" upper_limit="3.8"/>
                    <measurement group_id="O2" value="3.2" lower_limit="2.8" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Duration of Virus Shedding in Nasal Washes</title>
        <description>Determined separately by a) culture and b) reverse transcription polymerase chain reaction (RT-PCR)</description>
        <time_frame>Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28. Last day positive is reported.</time_frame>
        <population>Only participants who met the definition of infection with vaccine virus were included.</population>
        <group_list>
          <group group_id="O1">
            <title>RSV ΔNS2/Δ1313/I1314L Vaccine</title>
            <description>Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).&#xD;
RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops</description>
          </group>
          <group group_id="O2">
            <title>RSV 276 Vaccine</title>
            <description>Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).&#xD;
RSV 276: 10^5 PFU; administered as nose drops</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo at study entry (Day 0).&#xD;
Placebo: Isotonic diluent, administered as nose drops</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Virus Shedding in Nasal Washes</title>
          <description>Determined separately by a) culture and b) reverse transcription polymerase chain reaction (RT-PCR)</description>
          <population>Only participants who met the definition of infection with vaccine virus were included.</population>
          <units>days</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="22"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Culture positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="8" upper_limit="12"/>
                    <measurement group_id="O2" value="10" lower_limit="7" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RT-PCR positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" lower_limit="12" upper_limit="16"/>
                    <measurement group_id="O2" value="14" lower_limit="11" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titers</title>
        <description>Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.</description>
        <time_frame>Measured at Day 0 and Day 56</time_frame>
        <population>Study participants who received inoculation and were followed on study past Day 0 were included. One child from a set of twins was randomly selected and excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>RSV ΔNS2/Δ1313/I1314L Vaccine</title>
            <description>Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).&#xD;
RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops</description>
          </group>
          <group group_id="O2">
            <title>RSV 276 Vaccine</title>
            <description>Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).&#xD;
RSV 276: 10^5 PFU; administered as nose drops</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo at study entry (Day 0).&#xD;
Placebo: Isotonic diluent, administered as nose drops</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titers</title>
          <description>Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.</description>
          <population>Study participants who received inoculation and were followed on study past Day 0 were included. One child from a set of twins was randomly selected and excluded from the analysis.</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="25"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>% with &gt;=4 fold rise in RSV-PRNT</param_type>
            <param_value>60</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>42</ci_lower_limit>
            <ci_upper_limit>76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>% with &gt;=4 fold rise in RSV-PRNT</param_type>
            <param_value>92</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>76</ci_lower_limit>
            <ci_upper_limit>98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>% with &gt;=4 fold rise in RSV-PRNT</param_type>
            <param_value>0</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0</ci_lower_limit>
            <ci_upper_limit>22</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.</p_value_desc>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.</p_value_desc>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Serum RSV-neutralizing Antibody Titers</title>
        <description>Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay.</description>
        <time_frame>Measured at Day 56</time_frame>
        <population>Study participants who received inoculation and were followed on study past Day 0 were included. One child from a set of twins was randomly selected and excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>RSV ΔNS2/Δ1313/I1314L Vaccine</title>
            <description>Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).&#xD;
RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops</description>
          </group>
          <group group_id="O2">
            <title>RSV 276 Vaccine</title>
            <description>Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).&#xD;
RSV 276: 10^5 PFU; administered as nose drops</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo at study entry (Day 0).&#xD;
Placebo: Isotonic diluent, administered as nose drops</description>
          </group>
        </group_list>
        <measure>
          <title>Serum RSV-neutralizing Antibody Titers</title>
          <description>Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay.</description>
          <population>Study participants who received inoculation and were followed on study past Day 0 were included. One child from a set of twins was randomly selected and excluded from the analysis.</population>
          <units>log 2 titers</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="25"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" lower_limit="4.1" upper_limit="6.2"/>
                    <measurement group_id="O2" value="6.7" lower_limit="6.0" upper_limit="7.8"/>
                    <measurement group_id="O3" value="2.3" lower_limit="2.3" upper_limit="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum Antibody Titers to RSV F Glycoprotein</title>
        <description>Antibodies were assessed by Enzyme-linked Immunosorbent Assay (ELISA). A response was defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.</description>
        <time_frame>Measured at Day 0 and Day 56</time_frame>
        <population>Study participants who received inoculation and were followed on study past Day 0 were included. One child from a set of twins was randomly selected and excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>RSV ΔNS2/Δ1313/I1314L Vaccine</title>
            <description>Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).&#xD;
RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops</description>
          </group>
          <group group_id="O2">
            <title>RSV 276 Vaccine</title>
            <description>Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).&#xD;
RSV 276: 10^5 PFU; administered as nose drops</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo at study entry (Day 0).&#xD;
Placebo: Isotonic diluent, administered as nose drops</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum Antibody Titers to RSV F Glycoprotein</title>
          <description>Antibodies were assessed by Enzyme-linked Immunosorbent Assay (ELISA). A response was defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.</description>
          <population>Study participants who received inoculation and were followed on study past Day 0 were included. One child from a set of twins was randomly selected and excluded from the analysis.</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="25"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>% with &gt;=4 fold rise in RSV F protein</param_type>
            <param_value>60</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>42</ci_lower_limit>
            <ci_upper_limit>76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>% with &gt;=4 fold rise in RSV F protein</param_type>
            <param_value>92</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>76</ci_lower_limit>
            <ci_upper_limit>98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>% with &gt;=4 fold rise in RSV F protein</param_type>
            <param_value>0</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0</ci_lower_limit>
            <ci_upper_limit>22</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.</p_value_desc>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.</p_value_desc>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Serum Antibody Responses to RSV F Glycoprotein</title>
        <description>Serum antibody titers to RSV F glycoprotein were assessed by ELISA.</description>
        <time_frame>Measured at Day 56</time_frame>
        <population>Study participants who received inoculation and were followed on study past Day 0 were included. One child from a set of twins was randomly selected and excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>RSV ΔNS2/Δ1313/I1314L Vaccine</title>
            <description>Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).&#xD;
RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops</description>
          </group>
          <group group_id="O2">
            <title>RSV 276 Vaccine</title>
            <description>Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).&#xD;
RSV 276: 10^5 PFU; administered as nose drops</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo at study entry (Day 0).&#xD;
Placebo: Isotonic diluent, administered as nose drops</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Antibody Responses to RSV F Glycoprotein</title>
          <description>Serum antibody titers to RSV F glycoprotein were assessed by ELISA.</description>
          <population>Study participants who received inoculation and were followed on study past Day 0 were included. One child from a set of twins was randomly selected and excluded from the analysis.</population>
          <units>log 2 titers</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="25"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4" lower_limit="9.3" upper_limit="11.8"/>
                    <measurement group_id="O2" value="12.6" lower_limit="11.3" upper_limit="13.3"/>
                    <measurement group_id="O3" value="6.4" lower_limit="4.6" upper_limit="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Had RSV-associated Symptomatic, Medically Attended Respiratory and Febrile Illness, by Grade, Among Those Who Experienced Natural Infection With wt RSV During the Subsequent RSV Season</title>
        <description>The number of participants who had RSV-associated, symptomatic, medically attended respiratory and febrile illness (MAARI) among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal washes collected during illness visits for MAARI events or a &gt; 4-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events. A participant was only counted once in each MAARI category, and that was in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 5 and Table 6 in the protocol document.</description>
        <time_frame>Measured through participant's last study visit, up to a total of 6 to 10 months depending on when participants enrolled in the study</time_frame>
        <population>Only participants who had RSV detected in nasal washes or had greater than or equal to 4 fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events were included.</population>
        <group_list>
          <group group_id="O1">
            <title>RSV ΔNS2/Δ1313/I1314L Vaccine</title>
            <description>Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).&#xD;
RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops</description>
          </group>
          <group group_id="O2">
            <title>RSV 276 Vaccine</title>
            <description>Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).&#xD;
RSV 276: 10^5 PFU; administered as nose drops</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo at study entry (Day 0).&#xD;
Placebo: Isotonic diluent, administered as nose drops</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Had RSV-associated Symptomatic, Medically Attended Respiratory and Febrile Illness, by Grade, Among Those Who Experienced Natural Infection With wt RSV During the Subsequent RSV Season</title>
          <description>The number of participants who had RSV-associated, symptomatic, medically attended respiratory and febrile illness (MAARI) among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal washes collected during illness visits for MAARI events or a &gt; 4-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events. A participant was only counted once in each MAARI category, and that was in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 5 and Table 6 in the protocol document.</description>
          <population>Only participants who had RSV detected in nasal washes or had greater than or equal to 4 fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events were included.</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="11"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Medically Attended Fever</title>
              <category_list>
                <category>
                  <title>No adverse event</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medically Attended Otitis Media</title>
              <category_list>
                <category>
                  <title>No adverse event</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medically Attended URI</title>
              <category_list>
                <category>
                  <title>No adverse event</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medically Attended LRI</title>
              <category_list>
                <category>
                  <title>No adverse event</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Magnitude of Serum RSV-neutralizing Antibody Responses in the Vaccine and Placebo Recipients Who Experienced Natural Infection With wt RSV During the Subsequent RSV Season.</title>
        <description>Only participants who had RSV detected in nasal washes or a greater than or equal to 4-fold rise in serum antibodies during the subsequent RSV season were included. RSV-neutralizing antibody titers were measured pre- and post-RSV surveillance season subsequent to the time of the inoculation.</description>
        <time_frame>Measured through participant's last study visit, up to a total of 6 to 10 months depending on when participants enrolled in the study</time_frame>
        <population>Only participants who had RSV detected in nasal washes or a greater than or equal to 4-fold rise in serum antibodies during the subsequent RSV season were included. One child from a set of twins was randomly selected and excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>RSV ΔNS2/Δ1313/I1314L Vaccine</title>
            <description>Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).&#xD;
RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops</description>
          </group>
          <group group_id="O2">
            <title>RSV 276 Vaccine</title>
            <description>Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).&#xD;
RSV 276: 10^5 PFU; administered as nose drops</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo at study entry (Day 0).&#xD;
Placebo: Isotonic diluent, administered as nose drops</description>
          </group>
        </group_list>
        <measure>
          <title>Magnitude of Serum RSV-neutralizing Antibody Responses in the Vaccine and Placebo Recipients Who Experienced Natural Infection With wt RSV During the Subsequent RSV Season.</title>
          <description>Only participants who had RSV detected in nasal washes or a greater than or equal to 4-fold rise in serum antibodies during the subsequent RSV season were included. RSV-neutralizing antibody titers were measured pre- and post-RSV surveillance season subsequent to the time of the inoculation.</description>
          <population>Only participants who had RSV detected in nasal washes or a greater than or equal to 4-fold rise in serum antibodies during the subsequent RSV season were included. One child from a set of twins was randomly selected and excluded from the analysis.</population>
          <units>log 2 titers</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="11"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-RSV surveillance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="2.3" upper_limit="6.6"/>
                    <measurement group_id="O2" value="6.1" lower_limit="5.8" upper_limit="7.3"/>
                    <measurement group_id="O3" value="2.3" lower_limit="2.3" upper_limit="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-RSV surveillance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" lower_limit="7.7" upper_limit="10.8"/>
                    <measurement group_id="O2" value="10.6" lower_limit="8.0" upper_limit="11.3"/>
                    <measurement group_id="O3" value="5.9" lower_limit="4.5" upper_limit="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From study entry to end of study. The duration of follow-up for a given participant was between 6 and 10 months depending on time of enrollment.</time_frame>
      <desc>From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to DAIDS EAE Manual V2.0 (see References). From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.</desc>
      <group_list>
        <group group_id="E1">
          <title>RSV Delta NS2</title>
          <description>Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).&#xD;
RSV ΔNS2/Δ1313/I1314L: 10^6 plaque-forming units (PFU); administered as nose drops</description>
        </group>
        <group group_id="E2">
          <title>RSV 276</title>
          <description>Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).&#xD;
RSV 276: 10^5 PFU; administered as nose drops</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Participants received a single dose of placebo at study entry (Day 0). Placebo: Isotonic diluent, administered as nose drops</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>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="21" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Tympanic membrane disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Tympanic membrane hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye discharge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Frequent bowel movements</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Infantile vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Teething</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Purulent discharge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Sinusitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Viral rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Foreign body in ear</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Breath sounds abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Infant irritability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" 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="9" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" 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="2" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" 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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Melissa Allen, Director, IMPAACT Operations Center</name_or_title>
      <organization>Family Health International (FHI 360)</organization>
      <phone>(919) 405-1429</phone>
      <email>mallen@fhi360.org</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/NCT03227029
org study id: IMPAACT 2018
secondary id: 38405
nct id: NCT03227029
nct alias: NCT03422237
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study was to evaluate the infectivity, safety, and immunogenicity of the
      recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L
      or RSV 276 when delivered as nose drops to RSV-seronegative infants 6 to 24 months of age.

      This study was a companion study to Center for Immunization Research (CIR) 321.
Human respiratory syncytial virus (RSV) is the most common viral cause of serious acute lower
      respiratory illness (LRI) in infants and children under 5 years of age worldwide. This study
      evaluated the infectivity, safety, and immunogenicity of two recombinant live-attenuated RSV
      vaccines: RSV ΔNS2/Δ1313/I1314L and RSV 276. The vaccines were delivered as nose drops to
      RSV-seronegative infants 6 to 24 months of age.

      Participants were randomly assigned to receive a single dose of the RSV ΔNS2/Δ1313/I1314L
      vaccine, the RSV 276 vaccine, or placebo at study entry (Day 0).

      Participants could be enrolled in the study outside of RSV season, i.e., between April 1 and
      October 14 for most sites or-for sites with local RSV seasons that start earlier-as specified
      on a site-by-site basis in the manual of procedures. Participants remained on study until
      they completed the post-RSV season visit between April 1 and April 30 in the calendar year
      following enrollment. Participants' total study duration was between 6 and 13 months,
      depending on when they enrolled in the study. Participants attended several study visits
      throughout the study, which included physical examinations, blood collection, nasal washes,
      and/or nasal adsorption (nasosorption) specimen collection. Participants' parents or
      guardians were contacted by study staff at various times during the study to monitor
      participants' health.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With Solicited Adverse Events (AEs) by Grade
time frame: Measured from Day 0 through Day 28
description: Solicited adverse events included fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI). The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 5 and Table 6 in the protocol document.
measure: Number of Participants With Unsolicited AEs
time frame: Measured from Day 0 through Day 28
description: Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each unsolicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. AE grading (Grade 1- mild to Grade 4-life-threatening) was done by Division of AIDS (DAIDS) AE Grading table v2.0 (see References).
measure: Number of Participants With Serious Adverse Events (SAEs)
time frame: Measured from Day 0 through Day 56
description: A Serious Adverse Event (SAE) is an AE, whether considered related to the study product or not, that:
Results in death during the period of protocol-defined surveillance;
Is life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death were it more severe;
Requires inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting;
Results in a persistent or significant disability/incapacity;
Is a congenital anomaly or birth defect, OR
Is an important medical event that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
measure: Number of Participants Infected With RSV Vaccine Virus
time frame: Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28 for nasal washes, and at Days 0, 56 for serum RSV-neutralizing antibodies
description: Defined as 1) vaccine virus identified in a nasal wash from Study Day 0-28 (a binary outcome based on nasal washes); and/or 2) greater than or equal to 4-fold rise in RSV serum neutralizing antibody titer and/or serum enzyme-linked immunosorbent assay (ELISA) titer to the RSV F protein from study entry to Study Day 56
measure: Peak Titer of Vaccine Virus Shed
time frame: Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28
description: This is the highest value per participant of the titer of vaccine virus shed. It was measured by culture. Only participants who met the definition of infection with vaccine virus were included.
measure: Duration of Virus Shedding in Nasal Washes
time frame: Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28. Last day positive is reported.
description: Determined separately by a) culture and b) reverse transcription polymerase chain reaction (RT-PCR)
measure: Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titers
time frame: Measured at Day 0 and Day 56
description: Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.
measure: Serum RSV-neutralizing Antibody Titers
time frame: Measured at Day 56
description: Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay.
measure: Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum Antibody Titers to RSV F Glycoprotein
time frame: Measured at Day 0 and Day 56
description: Antibodies were assessed by Enzyme-linked Immunosorbent Assay (ELISA). A response was defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.
measure: Serum Antibody Responses to RSV F Glycoprotein
time frame: Measured at Day 56
description: Serum antibody titers to RSV F glycoprotein were assessed by ELISA.
measure: Number of Participants Who Had RSV-associated Symptomatic, Medically Attended Respiratory and Febrile Illness, by Grade, Among Those Who Experienced Natural Infection With wt RSV During the Subsequent RSV Season
time frame: Measured through participant's last study visit, up to a total of 6 to 10 months depending on when participants enrolled in the study
description: The number of participants who had RSV-associated, symptomatic, medically attended respiratory and febrile illness (MAARI) among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal washes collected during illness visits for MAARI events or a > 4-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events. A participant was only counted once in each MAARI category, and that was in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 5 and Table 6 in the protocol document.
measure: Magnitude of Serum RSV-neutralizing Antibody Responses in the Vaccine and Placebo Recipients Who Experienced Natural Infection With wt RSV During the Subsequent RSV Season.
time frame: Measured through participant's last study visit, up to a total of 6 to 10 months depending on when participants enrolled in the study
description: Only participants who had RSV detected in nasal washes or a greater than or equal to 4-fold rise in serum antibodies during the subsequent RSV season were included. RSV-neutralizing antibody titers were measured pre- and post-RSV surveillance season subsequent to the time of the inoculation.
arm group label: RSV ΔNS2/Δ1313/I1314L vaccine
arm group type: Experimental
description: Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
arm group label: RSV 276 vaccine
arm group type: Experimental
description: Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants received a single dose of placebo at study entry (Day 0).
intervention type: Biological
intervention name: RSV ΔNS2/Δ1313/I1314L
description: 10^6 plaque-forming units (PFU); administered as nose drops
arm group label: RSV ΔNS2/Δ1313/I1314L vaccine
intervention type: Biological
intervention name: RSV 276
description: 10^5 PFU; administered as nose drops
arm group label: RSV 276 vaccine
intervention type: Biological
intervention name: Placebo
description: Isotonic diluent, administered as nose drops
arm group label: Placebo
criteria: 
gender: All
minimum age: 6 Months
maximum age: 24 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Coleen Cunningham, MD
role: Study Chair
affiliation: Children's Health Center, DUMC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf
description: Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017)
url: http://rsc.niaid.nih.gov/clinical-research-sites/manual-expedited-reporting-adverse-events-daids
description: Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010
responsible party type: Sponsor
mesh term: Respiratory Syncytial Virus Infections
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 