<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/NCT01733862</url>
  </required_header>
  <id_info>
    <org_study_id>116929</org_study_id>
    <nct_id>NCT01733862</nct_id>
  </id_info>
  <brief_title>Study to Assess the Impact of Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis</brief_title>
  <official_title>A Study to Assess the Impact of Rotavirus Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis (RV GE) in Japan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      This study aims at assessing the impact of RV vaccination in hospitals in Nagoya City&#xD;
      (administrative district), Japan, where RV vaccines have been introduced since November 2011&#xD;
      and financial support for vaccination costs by Nagoya city, Japan have been implemented from&#xD;
      October 2012.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The electronic admission database or any other applicable database of the hospital will be&#xD;
      reviewed to identify hospitalized children/children with outpatient visits/emergency room&#xD;
      visits, less than five years of age who had been diagnosed with acute gastroenteritis (AGE)&#xD;
      or RV GE either by the International Classification of Diseases and Related Health Problems&#xD;
      10th Revision (ICD 10) diagnostic code (AA00-AA09 for intestinal infectious diseases and&#xD;
      A08.0 for RV specific GE) or by RV positive rapid diagnosis kit results.&#xD;
&#xD;
      Note: The outcomes for the outpatient and emergency room visits will be assessed only in case&#xD;
      the data for outpatient and emergency room visits can be obtained from at least one of the&#xD;
      study centers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2012</start_date>
  <completion_date type="Actual">February 8, 2017</completion_date>
  <primary_completion_date type="Actual">February 8, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years.</measure>
    <time_frame>From Nov 2007 to Oct 2016</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of RV GE hospitalizations among AGE hospitalizations in children less than five years of age.</measure>
    <time_frame>From Nov 2007 to Oct 2016</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of RV GE hospitalizations by age group in children less than five years of age.</measure>
    <time_frame>From Nov 2007 to Oct 2016</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of AGE hospitalizations among all hospitalized children aged less than five years.</measure>
    <time_frame>From Nov 2007 to Oct 2016</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of outpatient visits for AGE among all outpatient visits in children less than five years of age.</measure>
    <time_frame>From Nov 2007 to Oct 2016</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of outpatient visits for RV GE among all outpatient visits in children less than five years of age.</measure>
    <time_frame>From Nov 2007 to Oct 2016</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of outpatient visits for RV GE among AGE outpatient visits in children less than five years of age.</measure>
    <time_frame>From Nov 2007 to Oct 2016</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospitalizations for RV GE or AGE, overall, for each year, season in children less than five years of age.</measure>
    <time_frame>From Nov 2007 to Oct 2016</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of hospitalizations for RV GE among all emergency visits for RV GE in children less than five years of age.</measure>
    <time_frame>From Nov 2007 to Oct 2016</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">5394</enrollment>
  <condition>Infections, Rotavirus</condition>
  <condition>Rotavirus Vaccines</condition>
  <arm_group>
    <arm_group_label>Group Japan</arm_group_label>
    <description>Children less than five years of age, hospitalized for RV GE or AGE and children with outpatient or emergency room visits for RV GE or AGE, between November 2007 and October 2016 (i.e., before and after the introduction of RV vaccination in Japan) in any of the selected hospitals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection</intervention_name>
    <description>Data sheet. Data will be collected and is planned to be analysed at the following time points:&#xD;
Pre-vaccination period: Nov 2007 to Oct 2011, transition period: Nov 2011 to Oct 2012 and post vaccination period: Nov 2012 to Oct 2016.</description>
    <arm_group_label>Group Japan</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include children less than five years of age, hospitalized for RV&#xD;
        GE or AGE and children with outpatient or emergency room visits for RV GE or AGE, between&#xD;
        November 2007 and October 2016 (i.e., before and after the introduction of RV vaccination&#xD;
        in Japan) in any of the selected hospitals.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Children aged less than five years visiting hospitals for RV GE or AGE from 2007 to 2016,&#xD;
        who live in the study area.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Not applicable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>1824 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>457-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>457-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>457-85</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>466-8650</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>466-86</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>468-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>468-85</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <reference>
    <citation>Yoshikawa T, Matsuki T, Sato K, Mizuno M, Shibata M, Hasegawa S, Morita M, Iwasa M, Gopala K, Holl K. Impact of rotavirus vaccination on the burden of acute gastroenteritis in Nagoya city, Japan. Vaccine. 2018 Jan 25;36(4):527-534. doi: 10.1016/j.vaccine.2017.12.006. Epub 2017 Dec 13.</citation>
    <PMID>29248263</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>May 29, 2019</last_update_submitted>
  <last_update_submitted_qc>May 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Impact</keyword>
  <keyword>Vaccination</keyword>
  <keyword>Hospitalizations</keyword>
  <keyword>Rotavirus gastroenteritis</keyword>
  <keyword>Japan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotavirus Infections</mesh_term>
    <mesh_term>Gastroenteritis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01733862
org study id: 116929
nct id: NCT01733862
lead sponsor: 
This study aims at assessing the impact of RV vaccination in hospitals in Nagoya City
      (administrative district), Japan, where RV vaccines have been introduced since November 2011
      and financial support for vaccination costs by Nagoya city, Japan have been implemented from
      October 2012.
The electronic admission database or any other applicable database of the hospital will be
      reviewed to identify hospitalized children/children with outpatient visits/emergency room
      visits, less than five years of age who had been diagnosed with acute gastroenteritis (AGE)
      or RV GE either by the International Classification of Diseases and Related Health Problems
      10th Revision (ICD 10) diagnostic code (AA00-AA09 for intestinal infectious diseases and
      A08.0 for RV specific GE) or by RV positive rapid diagnosis kit results.

      Note: The outcomes for the outpatient and emergency room visits will be assessed only in case
      the data for outpatient and emergency room visits can be obtained from at least one of the
      study centers.
observational model: Ecologic or Community
time perspective: Retrospective
measure: Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years.
time frame: From Nov 2007 to Oct 2016
measure: Occurrence of RV GE hospitalizations among AGE hospitalizations in children less than five years of age.
time frame: From Nov 2007 to Oct 2016
measure: Occurrence of RV GE hospitalizations by age group in children less than five years of age.
time frame: From Nov 2007 to Oct 2016
measure: Occurrence of AGE hospitalizations among all hospitalized children aged less than five years.
time frame: From Nov 2007 to Oct 2016
measure: Occurrence of outpatient visits for AGE among all outpatient visits in children less than five years of age.
time frame: From Nov 2007 to Oct 2016
measure: Occurrence of outpatient visits for RV GE among all outpatient visits in children less than five years of age.
time frame: From Nov 2007 to Oct 2016
measure: Occurrence of outpatient visits for RV GE among AGE outpatient visits in children less than five years of age.
time frame: From Nov 2007 to Oct 2016
measure: Duration of hospitalizations for RV GE or AGE, overall, for each year, season in children less than five years of age.
time frame: From Nov 2007 to Oct 2016
measure: Occurrence of hospitalizations for RV GE among all emergency visits for RV GE in children less than five years of age.
time frame: From Nov 2007 to Oct 2016
arm group label: Group Japan
description: Children less than five years of age, hospitalized for RV GE or AGE and children with outpatient or emergency room visits for RV GE or AGE, between November 2007 and October 2016 (i.e., before and after the introduction of RV vaccination in Japan) in any of the selected hospitals.
intervention type: Other
intervention name: Data collection
description: Data sheet. Data will be collected and is planned to be analysed at the following time points:
Pre-vaccination period: Nov 2007 to Oct 2011, transition period: Nov 2011 to Oct 2012 and post vaccination period: Nov 2012 to Oct 2016.
arm group label: Group Japan
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 1824 Days
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
citation: Yoshikawa T, Matsuki T, Sato K, Mizuno M, Shibata M, Hasegawa S, Morita M, Iwasa M, Gopala K, Holl K. Impact of rotavirus vaccination on the burden of acute gastroenteritis in Nagoya city, Japan. Vaccine. 2018 Jan 25;36(4):527-534. doi: 10.1016/j.vaccine.2017.12.006. Epub 2017 Dec 13.
PMID: 29248263
responsible party type: Sponsor
mesh term: Rotavirus Infections
mesh term: Gastroenteritis