xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05992935</url>
    </required_header>
    <id_info>
      <org_study_id>mRNA-1403/1405-P101</org_study_id>
      <nct_id>NCT05992935</nct_id>
    </id_info>
    <brief_title>Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 49 Years of Age and 60 to 80 Years of Age.</brief_title>
    <official_title>A Phase 1, Randomized, Placebo-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405, Multivalent Candidate Vaccines to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 49 Years of Age and 60 to 80 Years of Age</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ModernaTX, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ModernaTX, Inc.</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 is to evaluate the safety, reactogenicity, and immunogenicity of&#xD;
        mRNA-1403 and mRNA-1405 in healthy adult participants 18 to 49 years of age and 60 to 80&#xD;
        years of age.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 25, 2023</start_date>
    <completion_date type="Anticipated">May 21, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 21, 2025</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)</measure>
      <time_frame>Up to Day 7 after each study intervention</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Unsolicited Adverse Events (AEs)</measure>
      <time_frame>Up to 28 days after each vaccination</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Medically Attended AEs (MAAEs)</measure>
      <time_frame>Day 1 through 6 months after last study intervention (Day 169)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Any SAEs, AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine, and AESIs</measure>
      <time_frame>Day 1 to end-of study (Day 365)</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Geometric Mean Titer (GMT) of Histo-Blood Group Antigen (HBGA) Blocking Antibodies Against Vaccine-matched Norovirus (NoV) Genotypes</measure>
      <time_frame>Days 1, 29, and 57</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geometric Mean Fold Rise (GMFR) of HBGA Blocking Antibodies Titers</measure>
      <time_frame>Days 1, 29, and 57</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with Seroresponse Based on HBGA Blocking Antibody Titer</measure>
      <time_frame>Days 29 and 57</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GMT of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes</measure>
      <time_frame>Days 1, 29, and 57</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GMFR of bAb Titers</measure>
      <time_frame>Days 1, 29, and 57</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with Seroresponse Based on bAb Titer</measure>
      <time_frame>Days 29 and 57</time_frame>
    </secondary_outcome>
    <number_of_arms>11</number_of_arms>
    <enrollment type="Anticipated">660</enrollment>
    <condition>Norovirus Acute Gastroenteritis</condition>
    <arm_group>
      <arm_group_label>mRNA-1403 Dose Level 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 2 intramuscular (IM) injections of mRNA-1403 at Dose Level 1.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1403 Dose Level 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 2 IM injections of mRNA-1403 at Dose Level 2.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1403 Dose Level 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 2 IM injections of mRNA-1403 at Dose Level 3.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1403 Dose Level 4 Regimen 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 2 IM injections of mRNA-1403 at Dose Level 4.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1403 Dose Level 4 Regimen 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 1 IM injection of mRNA-1403 at Dose Level 4 and 1 IM injection of study vaccine-matched placebo.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1405 Dose Level 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 2 IM injections of mRNA-1405 at Dose Level 1.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1405 Dose Level 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 2 IM injections of mRNA-1405 at Dose Level 2.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1405 Dose Level 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 2 IM injections of mRNA-1405 at Dose Level 3.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1405 Dose Level 4 Regimen 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 2 IM injections of mRNA-1405 at Dose Level 4.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1405 Dose Level 4 Regimen 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 1 IM injections of mRNA-1405 at Dose Level 4 and 1 IM injection of study vaccine-matched placebo.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will receive 2 IM injections of study vaccine-matching placebo.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>mRNA-1403</intervention_name>
      <description>Sterile liquid for injection</description>
      <arm_group_label>mRNA-1403 Dose Level 1</arm_group_label>
      <arm_group_label>mRNA-1403 Dose Level 2</arm_group_label>
      <arm_group_label>mRNA-1403 Dose Level 3</arm_group_label>
      <arm_group_label>mRNA-1403 Dose Level 4 Regimen 1</arm_group_label>
      <arm_group_label>mRNA-1403 Dose Level 4 Regimen 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>mRNA-1405</intervention_name>
      <description>Sterile liquid for injection</description>
      <arm_group_label>mRNA-1405 Dose Level 1</arm_group_label>
      <arm_group_label>mRNA-1405 Dose Level 2</arm_group_label>
      <arm_group_label>mRNA-1405 Dose Level 3</arm_group_label>
      <arm_group_label>mRNA-1405 Dose Level 4 Regimen 1</arm_group_label>
      <arm_group_label>mRNA-1405 Dose Level 4 Regimen 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>0.9% sodium chloride (normal saline) injection</description>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_label>mRNA-1403 Dose Level 4 Regimen 2</arm_group_label>
      <arm_group_label>mRNA-1405 Dose Level 4 Regimen 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            -  Adults 18 to 49 years of age at the time of consent or adults 60 to 80 years of age at&#xD;
               the time of consent.&#xD;
  &#xD;
            -  Body mass index of 18 to 39 kilogram/meter^2 (inclusive) at the Screening Visit.&#xD;
  &#xD;
            -  Participants assigned female at birth are eligible to participate if they are not&#xD;
               pregnant or breast/chest/body feeding.&#xD;
  &#xD;
            -  A person of childbearing potential is using a highly effective contraceptive method.&#xD;
  &#xD;
            -  Participant has provided written informed consent for participation in this study,&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  Is acutely ill or febrile (temperature ≥38.0°C [100.4°F]) 72 hours prior to or at the&#xD;
               Screening Visit or Day 1&#xD;
  &#xD;
            -  History of a diagnosis or condition that, in the judgment of the Investigator, is&#xD;
               clinically unstable or may affect participant safety, assessment of safety endpoints,&#xD;
               assessment of immune response, or adherence to study procedures.&#xD;
  &#xD;
            -  Has a medical, psychiatric, or occupational condition, including reported history of&#xD;
               substance abuse, that may pose additional risk as a result of participation, or that&#xD;
               could interfere with safety assessments or interpretation of results according to the&#xD;
               Investigator's judgment.&#xD;
  &#xD;
            -  Has a current or previous diagnosis of immunosuppressive condition, to include human&#xD;
               immunodeficiency virus, or immune-mediated (autoimmune) disease that requires&#xD;
               immunosuppressive therapies (drugs or biologics). The use of topical corticosteroids&#xD;
               or other immunosuppressive agents (for example, topical calcineurin inhibitor) may be&#xD;
               eligible for participation at the discretion of the Investigator.&#xD;
  &#xD;
            -  History of anaphylaxis, urticaria, or other significant AR requiring medical&#xD;
               intervention after receipt of a vaccine or intervention that includes one or more of&#xD;
               the same components contained in the study vaccine.&#xD;
  &#xD;
            -  Any history of myocarditis or pericarditis.&#xD;
  &#xD;
            -  Coagulopathy or bleeding disorder considered a contraindication to IM injection or&#xD;
               phlebotomy.&#xD;
  &#xD;
            -  Dermatologic conditions that could affect local solicited AR assessments (for example,&#xD;
               tattoos, psoriasis patches affecting skin over the deltoid areas).&#xD;
  &#xD;
            -  Has received systemic immunosuppressive therapies (drugs or biologics) for &gt;14 days in&#xD;
               total within 6 months prior to Screening (for corticosteroids ≥10 mg/day of prednisone&#xD;
               equivalent) or is anticipating the need for immunosuppressive treatment at any time&#xD;
               during participation in the study. Inhaled, nasal, intra-articular, and topical&#xD;
               steroids are allowed.&#xD;
  &#xD;
            -  Has received or plans to receive any licensed/authorized vaccine (to include severe&#xD;
               acute respiratory syndrome-related coronavirus-2 vaccine) ≤28 days prior to or within&#xD;
               28 days after each study intervention, with the exception of influenza vaccines, which&#xD;
               may be given 14 days before or after receipt of a study intervention.&#xD;
  &#xD;
            -  Has received systemic immunoglobulins or blood products within 3 months prior to the&#xD;
               Screening Visit or plans for receipt during the study.&#xD;
  &#xD;
            -  Has donated ≥450 mL of blood products within 28 days prior to the Screening Visit or&#xD;
               plans to donate blood products during the study.&#xD;
  &#xD;
            -  Participated in an interventional clinical study within 28 days prior to the Screening&#xD;
               Visit based on the medical history interview or plans to participate in an&#xD;
               interventional clinical trial of an investigational vaccine or drug while&#xD;
               participating in this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Moderna Clinical Trials Support Center</last_name>
      <phone>1-877-777-7187</phone>
      <email>clinicaltrials@modernatx.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>ARK Clinical Research, LLC</name>
        <address>
          <city>Long Beach</city>
          <state>California</state>
          <zip>90815</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Tekton Research, Inc - Longmont Center</name>
        <address>
          <city>Longmont</city>
          <state>Colorado</state>
          <zip>80501</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Centers of America</name>
        <address>
          <city>Hollywood</city>
          <state>Florida</state>
          <zip>33024</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Accel Research Sites Network</name>
        <address>
          <city>Decatur</city>
          <state>Georgia</state>
          <zip>30030</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Optimal Research</name>
        <address>
          <city>Peoria</city>
          <state>Illinois</state>
          <zip>61614</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research - Boise</name>
        <address>
          <city>Meridian Hills</city>
          <state>Indiana</state>
          <zip>83642</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Meridian Clinical Research, LLC</name>
        <address>
          <city>Sioux City</city>
          <state>Iowa</state>
          <zip>51106</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Johnson County Clin-Trials (JCCT)</name>
        <address>
          <city>Lenexa</city>
          <state>Kansas</state>
          <zip>66219</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Rockville Internal Medicine Group</name>
        <address>
          <city>Rockville</city>
          <state>Maryland</state>
          <zip>20854</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Meridian Clinical Research, LLC</name>
        <address>
          <city>Norfolk</city>
          <state>Nebraska</state>
          <zip>68701</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research</name>
        <address>
          <city>Omaha</city>
          <state>Nebraska</state>
          <zip>68134</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Rochester Clinical Research, Inc</name>
        <address>
          <city>Rochester</city>
          <state>New York</state>
          <zip>14609</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>C &amp; R Research Services USA / HHBA Health LLC</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77054</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Epic Medical Research, LLC</name>
        <address>
          <city>Red Oak</city>
          <state>Texas</state>
          <zip>75154</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>JBR Clinical Research</name>
        <address>
          <city>Salt Lake City</city>
          <state>Utah</state>
          <zip>84107</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>mRNA-1403</keyword>
    <keyword>mRNA-1405</keyword>
    <keyword>Norovirus</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gastroenteritis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05992935
  org study id: mRNA-1403/1405-P101
  nct id: NCT05992935
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of
        mRNA-1403 and mRNA-1405 in healthy adult participants 18 to 49 years of age and 60 to 80
        years of age.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
  time frame: Up to Day 7 after each study intervention
  measure: Number of Participants with Unsolicited Adverse Events (AEs)
  time frame: Up to 28 days after each vaccination
  measure: Number of Participants with Medically Attended AEs (MAAEs)
  time frame: Day 1 through 6 months after last study intervention (Day 169)
  measure: Number of Participants with Any SAEs, AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine, and AESIs
  time frame: Day 1 to end-of study (Day 365)
  measure: Geometric Mean Titer (GMT) of Histo-Blood Group Antigen (HBGA) Blocking Antibodies Against Vaccine-matched Norovirus (NoV) Genotypes
  time frame: Days 1, 29, and 57
  measure: Geometric Mean Fold Rise (GMFR) of HBGA Blocking Antibodies Titers
  time frame: Days 1, 29, and 57
  measure: Percentage of Participants with Seroresponse Based on HBGA Blocking Antibody Titer
  time frame: Days 29 and 57
  measure: GMT of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes
  time frame: Days 1, 29, and 57
  measure: GMFR of bAb Titers
  time frame: Days 1, 29, and 57
  measure: Percentage of Participants with Seroresponse Based on bAb Titer
  time frame: Days 29 and 57
  arm group label: mRNA-1403 Dose Level 1
  arm group type: Experimental
  description: Participants will receive 2 intramuscular (IM) injections of mRNA-1403 at Dose Level 1.
  arm group label: mRNA-1403 Dose Level 2
  arm group type: Experimental
  description: Participants will receive 2 IM injections of mRNA-1403 at Dose Level 2.
  arm group label: mRNA-1403 Dose Level 3
  arm group type: Experimental
  description: Participants will receive 2 IM injections of mRNA-1403 at Dose Level 3.
  arm group label: mRNA-1403 Dose Level 4 Regimen 1
  arm group type: Experimental
  description: Participants will receive 2 IM injections of mRNA-1403 at Dose Level 4.
  arm group label: mRNA-1403 Dose Level 4 Regimen 2
  arm group type: Experimental
  description: Participants will receive 1 IM injection of mRNA-1403 at Dose Level 4 and 1 IM injection of study vaccine-matched placebo.
  arm group label: mRNA-1405 Dose Level 1
  arm group type: Experimental
  description: Participants will receive 2 IM injections of mRNA-1405 at Dose Level 1.
  arm group label: mRNA-1405 Dose Level 2
  arm group type: Experimental
  description: Participants will receive 2 IM injections of mRNA-1405 at Dose Level 2.
  arm group label: mRNA-1405 Dose Level 3
  arm group type: Experimental
  description: Participants will receive 2 IM injections of mRNA-1405 at Dose Level 3.
  arm group label: mRNA-1405 Dose Level 4 Regimen 1
  arm group type: Experimental
  description: Participants will receive 2 IM injections of mRNA-1405 at Dose Level 4.
  arm group label: mRNA-1405 Dose Level 4 Regimen 2
  arm group type: Experimental
  description: Participants will receive 1 IM injections of mRNA-1405 at Dose Level 4 and 1 IM injection of study vaccine-matched placebo.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Participants will receive 2 IM injections of study vaccine-matching placebo.
  intervention type: Biological
  intervention name: mRNA-1403
  description: Sterile liquid for injection
  arm group label: mRNA-1403 Dose Level 1
  arm group label: mRNA-1403 Dose Level 2
  arm group label: mRNA-1403 Dose Level 3
  arm group label: mRNA-1403 Dose Level 4 Regimen 1
  arm group label: mRNA-1403 Dose Level 4 Regimen 2
  intervention type: Biological
  intervention name: mRNA-1405
  description: Sterile liquid for injection
  arm group label: mRNA-1405 Dose Level 1
  arm group label: mRNA-1405 Dose Level 2
  arm group label: mRNA-1405 Dose Level 3
  arm group label: mRNA-1405 Dose Level 4 Regimen 1
  arm group label: mRNA-1405 Dose Level 4 Regimen 2
  intervention type: Biological
  intervention name: Placebo
  description: 0.9% sodium chloride (normal saline) injection
  arm group label: Placebo
  arm group label: mRNA-1403 Dose Level 4 Regimen 2
  arm group label: mRNA-1405 Dose Level 4 Regimen 2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Moderna Clinical Trials Support Center
  phone: 1-877-777-7187
  email: clinicaltrials@modernatx.com
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Gastroenteritis