<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/NCT02252029</url>
  </required_header>
  <id_info>
    <org_study_id>OVG 2014/04</org_study_id>
    <nct_id>NCT02252029</nct_id>
  </id_info>
  <brief_title>Rotavirus Vaccine in Premature Babies</brief_title>
  <acronym>RotaNeo</acronym>
  <official_title>RotaNeo: Evaluation of Rotavirus Vaccine Administration in Premature Babies in the Neonatal Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will establish the duration of excretion of rotavirus vaccine in stool following&#xD;
      vaccination of premature babies hospitalised in a neonatal unit at the time of vaccination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rotavirus is the commonest cause of severe gastroenteritis in young children, and premature&#xD;
      babies are at high risk of serious disease. The RV1 rotavirus vaccine is an altered form of&#xD;
      the virus and is given to all children at 8 weeks and 12 weeks of age in the UK. It is given&#xD;
      by mouth and excreted in the stool following vaccination - the vaccine virus can therefore be&#xD;
      transmitted between people in the same way as the normal virus. Premature babies often&#xD;
      receive their initial vaccines while they are still hospitalised in neonatal units. There are&#xD;
      no data regarding stool excretion of the RV1 rotavirus vaccine in premature babies - there is&#xD;
      a theoretical risk of transmission of the vaccine virus to other babies in the unit (if there&#xD;
      was inadequate staff hand washing). Some countries have therefore advised against&#xD;
      immunisation of babies while in the neonatal unit. In the UK, however, the vaccine is being&#xD;
      given in neonatal units, enabling evaluation of the vaccine in hospitalised premature babies.&#xD;
&#xD;
      This is an observational study of babies admitted to the neonatal unit at the John Radcliffe&#xD;
      Hospital, Oxford University Hospitals NHS Trust who receive their first dose of rotavirus&#xD;
      vaccine during their hospital stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of days rotavirus vaccine can be detected in stool following immunisation</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of serum and stool antibody to rotavirus vaccine following vaccination</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events following rotavirus vaccine</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of vaccine responses after categorisation based on GI microbiome</measure>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Gastroenteritis</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Stool, serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Premature babies receiving their first dose of rotavirus vaccine while an inpatient on the&#xD;
        neonatal unit at the John Radcliffe Hospital, Oxford University Hospitals NHS Trust&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant's parent is willing and able to give informed consent for participation in&#xD;
             the study.&#xD;
&#xD;
          -  Current inpatient in the neonatal unit and expected to remain an inpatient for at&#xD;
             least 14 days following immunisation with rotavirus vaccine.&#xD;
&#xD;
          -  Due to receive rotavirus vaccination during their admission.&#xD;
&#xD;
          -  Born at less than 37 completed weeks gestation (i.e. up to and including 36 weeks and&#xD;
             6 days)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Parent is listed on the study delegation log.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Weeks</minimum_age>
    <maximum_age>15 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Pollard</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oxford</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Paediatrics, University of Oxford</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxford University Hospitals NHS Trust</name>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>May 8, 2017</last_update_submitted>
  <last_update_submitted_qc>May 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rotavirus</keyword>
  <keyword>Vaccine</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>


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/NCT02252029
org study id: OVG 2014/04
nct id: NCT02252029
lead sponsor: 
has dmc: No
This study will establish the duration of excretion of rotavirus vaccine in stool following
      vaccination of premature babies hospitalised in a neonatal unit at the time of vaccination.
Rotavirus is the commonest cause of severe gastroenteritis in young children, and premature
      babies are at high risk of serious disease. The RV1 rotavirus vaccine is an altered form of
      the virus and is given to all children at 8 weeks and 12 weeks of age in the UK. It is given
      by mouth and excreted in the stool following vaccination - the vaccine virus can therefore be
      transmitted between people in the same way as the normal virus. Premature babies often
      receive their initial vaccines while they are still hospitalised in neonatal units. There are
      no data regarding stool excretion of the RV1 rotavirus vaccine in premature babies - there is
      a theoretical risk of transmission of the vaccine virus to other babies in the unit (if there
      was inadequate staff hand washing). Some countries have therefore advised against
      immunisation of babies while in the neonatal unit. In the UK, however, the vaccine is being
      given in neonatal units, enabling evaluation of the vaccine in hospitalised premature babies.

      This is an observational study of babies admitted to the neonatal unit at the John Radcliffe
      Hospital, Oxford University Hospitals NHS Trust who receive their first dose of rotavirus
      vaccine during their hospital stay.
observational model: Cohort
time perspective: Prospective
measure: Number of days rotavirus vaccine can be detected in stool following immunisation
time frame: 24 months
measure: Measurement of serum and stool antibody to rotavirus vaccine following vaccination
time frame: 24 months
measure: Number of adverse events following rotavirus vaccine
time frame: 12 months
measure: Comparison of vaccine responses after categorisation based on GI microbiome
Stool, serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Weeks
maximum age: 15 Weeks
healthy volunteers: No
last name: Andrew Pollard
role: Principal Investigator
affiliation: University of Oxford
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Gastroenteritis