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/NCT06025695</url>
    </required_header>
    <id_info>
      <org_study_id>212692</org_study_id>
      <secondary_id>2020-000972-38</secondary_id>
      <nct_id>NCT06025695</nct_id>
    </id_info>
    <brief_title>Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks</brief_title>
    <official_title>A Phase III, Observer-blind, Randomized, Multicenter Study to Evaluate Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid as Compared to GSK's Rotarix Liquid, Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>GlaxoSmithKline</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>GlaxoSmithKline</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of the&#xD;
        Porcine circovirus (PCV)-free liquid formulation of GlaxoSmithKline Biologicals' SA (GSK)&#xD;
        oral live attenuated human rotavirus (HRV) study intervention compared to GSK's liquid oral&#xD;
        live attenuated HRV study intervention in healthy Chinese infants 6 to 16 weeks of age at the&#xD;
        time of the first study intervention administration.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 22, 2024</primary_completion_date>
    <phase>Phase 3</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>
      <masking_description>This study will be conducted in an observer-blind manner.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of seroconverted participants for anti-rotavirus (RV) immunoglobulin A (IgA) antibody (Ab)</measure>
      <time_frame>At Month 2 (1 month post-Dose 2)</time_frame>
      <description>A seroconverted participant is a participant who was initially seronegative (i.e., with anti-RV IgA Ab concentration below [&lt;] 20 unit per milliliter [U/mL] prior to the first dose of study intervention) and developed anti-RV IgA Ab concentration greater than or equal to (&gt;=) 20 U/mL at Month 2 (1 month post Dose 2).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum anti-RV IgA Ab concentrations expressed as geometric mean concentrations (GMCs)</measure>
      <time_frame>At Month 2 (1 month post-Dose 2)</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with serum anti-RV IgA Ab concentrations &gt;= 90 U/mL</measure>
      <time_frame>At Month 2 (1 month post-Dose 2)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants reporting solicited systemic events</measure>
      <time_frame>Within 14 days after each study intervention administration occurring at Day 1 and Month 1</time_frame>
      <description>Solicited systemic events include fever, diarrhea, vomiting, irritability/fussiness, loss of appetite, cough/runny nose. Fever is defined as body temperature &gt;= 37.5 degrees Celsius (°C) and the preferred location for measuring temperature is the axilla.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants reporting unsolicited adverse events (AEs)</measure>
      <time_frame>Within 31 days after each study intervention administration occurring at Day 1 and Month 1</time_frame>
      <description>Unsolicited AEs include any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants reporting serious adverse events (SAEs)</measure>
      <time_frame>From Dose 1 (Day 1) of the study intervention up to study end (Month 7)</time_frame>
      <description>An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or in other situations that are considered serious per medical or scientific judgment.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Gastroenteritis</condition>
    <arm_group>
      <arm_group_label>HRV Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants receive 2 doses of GSK's liquid oral live attenuated HRV study intervention administered at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HRV PCV-free Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants receive 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention administered at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China.</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>GSK's liquid oral live attenuated HRV</intervention_name>
      <description>2 doses of GSK's liquid oral live attenuated HRV study intervention administered orally at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China.</description>
      <arm_group_label>HRV Group</arm_group_label>
      <other_name>Rotarix</other_name>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>PCV-free liquid formulation of GSK's oral live attenuated HRV</intervention_name>
      <description>2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention administered orally at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.</description>
      <arm_group_label>HRV PCV-free Group</arm_group_label>
      <other_name>Rotarix PCV-free</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants' parent(s)/legally acceptable representative(s) [LAR(s)], who, in the&#xD;
               opinion of the investigator, can and will comply with the requirements of the&#xD;
               protocol.&#xD;
  &#xD;
            -  Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s)&#xD;
               of the participant prior to performance of any study specific procedure.&#xD;
  &#xD;
            -  A male or female with Chinese origin, between, and including, 6 and 16 weeks (42-112&#xD;
               days) of age at the time of the first study intervention administration.&#xD;
  &#xD;
            -  Healthy participants as established by medical history and clinical examination before&#xD;
               entering into the study.&#xD;
  &#xD;
            -  Born after a gestation period of 36 to 42 weeks inclusive.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Medical conditions&#xD;
  &#xD;
            -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on&#xD;
               medical history and physical examination (no laboratory testing required).&#xD;
  &#xD;
            -  History of severe combined immunodeficiency.&#xD;
  &#xD;
            -  History of any reaction or hypersensitivity likely to be exacerbated by any component&#xD;
               of the study intervention.&#xD;
  &#xD;
            -  History of seizures or progressive neurological disease.&#xD;
  &#xD;
            -  Family history of congenital or hereditary immunodeficiency.&#xD;
  &#xD;
            -  Uncorrected congenital malformation of the gastrointestinal tract that would&#xD;
               predispose for intussusception (IS).&#xD;
  &#xD;
            -  History of IS.&#xD;
  &#xD;
            -  Major congenital defects, or serious chronic illness as assessed by the investigator.&#xD;
  &#xD;
            -  Previous confirmed occurrence of rotavirus gastroenteritis (RVGE).&#xD;
  &#xD;
            -  Participants with confirmed or suspected Coronavirus Disease 2019 (COVID-19).&#xD;
  &#xD;
          Prior/Concomitant therapy&#xD;
  &#xD;
            -  Use of any investigational or non-registered product other than the study&#xD;
               interventions during the period beginning 30 days before the first dose of study&#xD;
               interventions (Day -29 to Day 1), or planned use during the study period.&#xD;
  &#xD;
            -  Planned administration/administration of a vaccine not foreseen by the study protocol&#xD;
               in the period starting 30 days before the first dose and ending 30 days after the&#xD;
               second dose of study intervention administration*, with the exception of the&#xD;
               inactivated influenza vaccine, which is allowed at any time during the study and other&#xD;
               licensed routine childhood vaccinations.&#xD;
  &#xD;
               *In case emergency mass vaccination for an unforeseen public health threat (e.g., a&#xD;
               pandemic) is organized by public health authorities outside the routine immunization&#xD;
               programme, the time period described above can be reduced if, necessary for that mass&#xD;
               vaccination vaccine, provided it is licensed and used according to its Product&#xD;
               Information.&#xD;
  &#xD;
            -  Administration of immunoglobulins and/or any blood products or plasma derivatives from&#xD;
               birth or planned administration during the study period.&#xD;
  &#xD;
            -  Administration of long-acting immune-modifying drugs from birth or planned&#xD;
               administration at any time during the study period.&#xD;
  &#xD;
            -  Chronic administration of immunosuppressants or other immune-modifying drugs since&#xD;
               birth. For corticosteroids, this will mean prednisone &gt;= 0.5 milligram/kilogram&#xD;
               (kg)/day, or equivalent. Inhaled and topical steroids are allowed.&#xD;
  &#xD;
            -  Previous vaccination against RV.&#xD;
  &#xD;
          Prior/Concurrent clinical study experience&#xD;
  &#xD;
          - Concurrently participating in another clinical study, at any time during the study&#xD;
          period, in which the participant has been or will be exposed to an investigational or a&#xD;
          non-investigational vaccine/product.&#xD;
  &#xD;
          Other exclusions&#xD;
  &#xD;
          - Child in care.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Weeks</minimum_age>
      <maximum_age>16 Weeks</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>EU GSK Clinical Trials Call Center</last_name>
      <phone>+44 (0) 20 89904466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <zip>610041</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Mianyang</city>
          <state>Sichuan</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Nanchong</city>
          <state>Sichuan</state>
          <zip>637300</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Neijiang</city>
          <state>Sichuan</state>
          <zip>641200</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Kunming</city>
          <state>Yunnan</state>
          <zip>650034</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Miyang Town, Mile City, Honghe Autonomous Prefectu</city>
          <state>Yunnan</state>
          <zip>652399</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Wenshan</city>
          <state>Yunnan</state>
          <zip>663300</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Tengchong</city>
          <zip>679100</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Rotavirus (RV)</keyword>
    <keyword>Human rotavirus (HRV)</keyword>
    <keyword>Rotarix Porcine circovirus (PCV)-free liquid</keyword>
    <keyword>Rotarix liquid</keyword>
    <keyword>Healthy Chinese infants</keyword>
    <keyword>Immunogenicity</keyword>
    <keyword>Reactogenicity</keyword>
    <keyword>Safety</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gastroenteritis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.</ipd_time_frame>
      <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06025695
  org study id: 212692
  secondary id: 2020-000972-38
  nct id: NCT06025695
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of the
        Porcine circovirus (PCV)-free liquid formulation of GlaxoSmithKline Biologicals' SA (GSK)
        oral live attenuated human rotavirus (HRV) study intervention compared to GSK's liquid oral
        live attenuated HRV study intervention in healthy Chinese infants 6 to 16 weeks of age at the
        time of the first study intervention administration.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: This study will be conducted in an observer-blind manner.
  measure: Percentage of seroconverted participants for anti-rotavirus (RV) immunoglobulin A (IgA) antibody (Ab)
  time frame: At Month 2 (1 month post-Dose 2)
  description: A seroconverted participant is a participant who was initially seronegative (i.e., with anti-RV IgA Ab concentration below [<] 20 unit per milliliter [U/mL] prior to the first dose of study intervention) and developed anti-RV IgA Ab concentration greater than or equal to (>=) 20 U/mL at Month 2 (1 month post Dose 2).
  measure: Serum anti-RV IgA Ab concentrations expressed as geometric mean concentrations (GMCs)
  time frame: At Month 2 (1 month post-Dose 2)
  measure: Percentage of participants with serum anti-RV IgA Ab concentrations >= 90 U/mL
  time frame: At Month 2 (1 month post-Dose 2)
  measure: Percentage of participants reporting solicited systemic events
  time frame: Within 14 days after each study intervention administration occurring at Day 1 and Month 1
  description: Solicited systemic events include fever, diarrhea, vomiting, irritability/fussiness, loss of appetite, cough/runny nose. Fever is defined as body temperature >= 37.5 degrees Celsius (°C) and the preferred location for measuring temperature is the axilla.
  measure: Percentage of participants reporting unsolicited adverse events (AEs)
  time frame: Within 31 days after each study intervention administration occurring at Day 1 and Month 1
  description: Unsolicited AEs include any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
  measure: Percentage of participants reporting serious adverse events (SAEs)
  time frame: From Dose 1 (Day 1) of the study intervention up to study end (Month 7)
  description: An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or in other situations that are considered serious per medical or scientific judgment.
  arm group label: HRV Group
  arm group type: Active Comparator
  description: Participants receive 2 doses of GSK's liquid oral live attenuated HRV study intervention administered at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China.
  arm group label: HRV PCV-free Group
  arm group type: Experimental
  description: Participants receive 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention administered at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China.
  intervention type: Combination Product
  intervention name: GSK's liquid oral live attenuated HRV
  description: 2 doses of GSK's liquid oral live attenuated HRV study intervention administered orally at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China.
  arm group label: HRV Group
  other name: Rotarix
  intervention type: Combination Product
  intervention name: PCV-free liquid formulation of GSK's oral live attenuated HRV
  description: 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention administered orally at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
  arm group label: HRV PCV-free Group
  other name: Rotarix PCV-free
  criteria: 
  gender: All
  minimum age: 6 Weeks
  maximum age: 16 Weeks
  healthy volunteers: Accepts Healthy Volunteers
  last name: US GSK Clinical Trials Call Center
  phone: 877-379-3718
  email: GSKClinicalSupportHD@gsk.com
  last name: EU GSK Clinical Trials Call Center
  phone: +44 (0) 20 89904466
  email: GSKClinicalSupportHD@gsk.com
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Gastroenteritis
  sharing ipd: Yes
  ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
  ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.