<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/NCT02992197</url>
  </required_header>
  <id_info>
    <org_study_id>CHRMS 17-0166</org_study_id>
    <nct_id>NCT02992197</nct_id>
  </id_info>
  <brief_title>The Effects of Increased Inoculum on Oral Rotavirus Vaccine Take and Immunogenicity</brief_title>
  <official_title>A Double-blind, Randomized Controlled Trial of the Effect of Vaccine Inoculum on Oral Rotavirus Vaccine (Rotarix, GlaxoSmithKline) Take and Immunogenicity in Dhaka, Bangladesh</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Vermont</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Charles H. Hood Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Thrasher Research Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Vermont</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rotavirus is the leading cause of diarrhea in children worldwide. Oral rotavirus vaccines&#xD;
      work remarkably well in high-income countries, but for unclear reasons they underperform in&#xD;
      low-income countries. A double-blind, randomized control trial will be performed to evaluate&#xD;
      whether using a higher dose of a currently licensed vaccine (Rotarix, GlaxoSmithKline) can&#xD;
      improve immune responses among infants in Dhaka, Bangladesh.&#xD;
&#xD;
      Infants will be randomized 1:1 to receive either a standard or a double dose of Rotarix at 6&#xD;
      and 10 weeks of life. Infants will be assessed for fecal vaccine shedding and serum&#xD;
      rotavirus-specific IgA responses to determine vaccine immunogenicity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2017</start_date>
  <completion_date type="Actual">June 7, 2018</completion_date>
  <primary_completion_date type="Actual">June 7, 2018</primary_completion_date>
  <phase>Phase 4</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 (or Percentage) of Infants in Each Study Arm Who Test Positive for Fecal Rotavirus Vaccine-strain Virus Shedding Post-vaccination</measure>
    <time_frame>Measured through week 12 of life</time_frame>
    <description>This will be an aggregate measure demonstrating a change from baseline. Infants will have stool collected immediately prior to Rotarix vaccination at weeks 6 and 10 of life, then 4, 7, and 14 days following each dose (i.e. last assessment at week 12 of life). Each specimen will be assessed for vaccine-strain virus (i.e. fecal vaccine shedding) at each time point by polymerase chain reaction. Any child who has a change in fecal vaccine shedding status, from negative at baseline (6 weeks) to positive at any subsequent time point, will be categorized as having met the outcome measure for positive fecal vaccine shedding.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number (or Percentage) of Infants in Each Study Arm With Rotavirus-specific Plasma Immunoglobulin A (IgA) Seroconversion Post-vaccination</measure>
    <time_frame>Measured at week 14 of life</time_frame>
    <description>This outcome will measure seroconversion, i.e. the change in plasma rotavirus-specific IgA concentration at week 14 of life compared to week 6 of life (baseline). Blood will be collected from infants prior to the first dose of Rotarix at week 6 of life and again at week 14 of life (4 weeks following the second dose) for measurement of plasma rotavirus-specific IgA by enzyme immunoassay. Infants will be assessed for seroconversion (IgA concentration &lt;=20 U/mL pre-vaccination and &gt;20 post-vaccination). Infants who demonstrate rotavirus-specific IgA seroconversion will be categorized as having met the outcome measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number (or Percentage) of Infants in Each Study Arm With Successful Vaccine Take, Defined as Positive Fecal Vaccine Shedding Post-vaccination OR Rotavirus-specific Plasma IgA Seroconversion Post-vaccination</measure>
    <time_frame>Measured at week 14 of life</time_frame>
    <description>Vaccine take is an aggregate, dichotomous immunogenicity measure (successful vaccine take vs no vaccine take). Infants positive for either fecal vaccine shedding OR plasma rotavirus-specific IgA seroconversion (as described in Outcomes 1 and 2, respectively) will be categorized as having met the outcome measure of successful vaccine take. Those who met neither outcome will be categorized as no vaccine take.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>Rotavirus Infection</condition>
  <condition>Vaccine Response Impaired</condition>
  <condition>Vaccine Virus Shedding</condition>
  <arm_group>
    <arm_group_label>Rotarix, single dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rotarix, double dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Rotarix, dose 1</intervention_name>
    <description>Rotarix, dose 1</description>
    <arm_group_label>Rotarix, double dose</arm_group_label>
    <arm_group_label>Rotarix, single dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Rotarix, dose 2</intervention_name>
    <description>Rotarix, dose 2</description>
    <arm_group_label>Rotarix, double dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (for Rotarix dose 2)</intervention_name>
    <description>Sterile water to provide volume equivalent as a second dose of Rotarix</description>
    <arm_group_label>Rotarix, single dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Generally healthy infant (as determined by medical officers)&#xD;
&#xD;
          2. Age 0-7 days at enrolment&#xD;
&#xD;
          3. Mother willing and able to provide signed informed consent&#xD;
&#xD;
          4. Mother willing to allow infant to be vaccinated according to study schedule&#xD;
&#xD;
          5. Mother willing to allow biological specimens, including blood, stool, and saliva, to&#xD;
             be collected from infant according to study protocol&#xD;
&#xD;
          6. Mother willing and able to adhere to study schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Obvious congenital malformation&#xD;
&#xD;
          2. Birth weight (if known) or enrolment weight (if birth weight unknown) &lt; 2000 gm&#xD;
&#xD;
          3. Known immunocompromising condition in infant&#xD;
&#xD;
          4. Enrolment in other vaccine research trials&#xD;
&#xD;
          5. Other household member enrolled in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>15 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benjamin Lee, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Vermont</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>International Center for Diarrhoeal Disease Research, Bangladesh (icddr,b)</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <results_first_submitted>June 30, 2020</results_first_submitted>
  <results_first_submitted_qc>June 30, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 17, 2020</results_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Vermont</investigator_affiliation>
    <investigator_full_name>Benjamin Lee</investigator_full_name>
    <investigator_title>Assistant Professor, Department of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Rotavirus</keyword>
  <keyword>Oral vaccines</keyword>
  <keyword>Vaccine underperformance</keyword>
  <keyword>Vaccine shedding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 24, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT02992197/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Rotarix, Single Dose</title>
          <description>Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life&#xD;
Rotarix, dose 1: Rotarix, dose 1&#xD;
Placebo (for Rotarix dose 2): Sterile water to provide volume equivalent as a second dose of Rotarix</description>
        </group>
        <group group_id="P2">
          <title>Rotarix, Double Dose</title>
          <description>Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life&#xD;
Rotarix, dose 1: Rotarix, dose 1&#xD;
Rotarix, dose 2: Rotarix, dose 2</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="110"/>
                <participants group_id="P2" count="110"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
                <participants group_id="P2" count="103"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The a priori primary analysis was designed to evaluate study outcomes among those who completed the study per-protocol. Due to anticipated levels of attrition, the per-protocol population differs from the total numbers of initial enrollees. Data presented are for the per protocol population.</population>
      <group_list>
        <group group_id="B1">
          <title>Rotarix, Single Dose</title>
          <description>Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life&#xD;
Rotarix, dose 1: Rotarix, dose 1&#xD;
Placebo (for Rotarix dose 2): Sterile water to provide volume equivalent as a second dose of Rotarix</description>
        </group>
        <group group_id="B2">
          <title>Rotarix, Double Dose</title>
          <description>Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life&#xD;
Rotarix, dose 1: Rotarix, dose 1&#xD;
Rotarix, dose 2: Rotarix, dose 2</description>
        </group>
        <group group_id="B3">
          <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="97"/>
            <count group_id="B2" value="92"/>
            <count group_id="B3" value="189"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="189"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.8" spread="1.8"/>
                    <measurement group_id="B2" value="5.0" spread="1.8"/>
                    <measurement group_id="B3" value="4.9" spread="1.8"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </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>Bangladesh</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Birth place</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Home birth</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hospital/clinic birth</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mode of delivery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Vaginal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="105"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Caesarean section</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.81" spread="0.44"/>
                    <measurement group_id="B2" value="2.86" spread="0.38"/>
                    <measurement group_id="B3" value="2.83" spread="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Length</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.9" spread="2.6"/>
                    <measurement group_id="B2" value="48.7" spread="0.21"/>
                    <measurement group_id="B3" value="48.8" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Head circumference</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.1" spread="1.3"/>
                    <measurement group_id="B2" value="34.2" spread="1.3"/>
                    <measurement group_id="B3" value="34.1" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Water treatment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>None</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Water filter</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Boil</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of toilet</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Septic tank or toilet</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Water-sealed or slab latrine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pit latrine or open latrine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Open drain beside home</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Family demographics</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Mother's education &lt;= secondary</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Father's education &lt;= secondary</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homeowner</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any food deficit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Municipal (piped) water source</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Monthly household income in Taka</title>
          <units>Taka</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15000" lower_limit="10000" upper_limit="20000"/>
                    <measurement group_id="B2" value="15000" lower_limit="10000" upper_limit="20000"/>
                    <measurement group_id="B3" value="15000" lower_limit="10000" upper_limit="20000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number (or Percentage) of Infants in Each Study Arm Who Test Positive for Fecal Rotavirus Vaccine-strain Virus Shedding Post-vaccination</title>
        <description>This will be an aggregate measure demonstrating a change from baseline. Infants will have stool collected immediately prior to Rotarix vaccination at weeks 6 and 10 of life, then 4, 7, and 14 days following each dose (i.e. last assessment at week 12 of life). Each specimen will be assessed for vaccine-strain virus (i.e. fecal vaccine shedding) at each time point by polymerase chain reaction. Any child who has a change in fecal vaccine shedding status, from negative at baseline (6 weeks) to positive at any subsequent time point, will be categorized as having met the outcome measure for positive fecal vaccine shedding.</description>
        <time_frame>Measured through week 12 of life</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Rotarix, Single Dose</title>
            <description>Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life&#xD;
Rotarix, dose 1: Rotarix, dose 1&#xD;
Placebo (for Rotarix dose 2): Sterile water to provide volume equivalent as a second dose of Rotarix</description>
          </group>
          <group group_id="O2">
            <title>Rotarix, Double Dose</title>
            <description>Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life&#xD;
Rotarix, dose 1: Rotarix, dose 1&#xD;
Rotarix, dose 2: Rotarix, dose 2</description>
          </group>
        </group_list>
        <measure>
          <title>Number (or Percentage) of Infants in Each Study Arm Who Test Positive for Fecal Rotavirus Vaccine-strain Virus Shedding Post-vaccination</title>
          <description>This will be an aggregate measure demonstrating a change from baseline. Infants will have stool collected immediately prior to Rotarix vaccination at weeks 6 and 10 of life, then 4, 7, and 14 days following each dose (i.e. last assessment at week 12 of life). Each specimen will be assessed for vaccine-strain virus (i.e. fecal vaccine shedding) at each time point by polymerase chain reaction. Any child who has a change in fecal vaccine shedding status, from negative at baseline (6 weeks) to positive at any subsequent time point, will be categorized as having met the outcome measure for positive fecal vaccine shedding.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number (or Percentage) of Infants in Each Study Arm With Rotavirus-specific Plasma Immunoglobulin A (IgA) Seroconversion Post-vaccination</title>
        <description>This outcome will measure seroconversion, i.e. the change in plasma rotavirus-specific IgA concentration at week 14 of life compared to week 6 of life (baseline). Blood will be collected from infants prior to the first dose of Rotarix at week 6 of life and again at week 14 of life (4 weeks following the second dose) for measurement of plasma rotavirus-specific IgA by enzyme immunoassay. Infants will be assessed for seroconversion (IgA concentration &lt;=20 U/mL pre-vaccination and &gt;20 post-vaccination). Infants who demonstrate rotavirus-specific IgA seroconversion will be categorized as having met the outcome measure.</description>
        <time_frame>Measured at week 14 of life</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Rotarix, Single Dose</title>
            <description>Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life&#xD;
Rotarix, dose 1: Rotarix, dose 1&#xD;
Placebo (for Rotarix dose 2): Sterile water to provide volume equivalent as a second dose of Rotarix</description>
          </group>
          <group group_id="O2">
            <title>Rotarix, Double Dose</title>
            <description>Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life&#xD;
Rotarix, dose 1: Rotarix, dose 1&#xD;
Rotarix, dose 2: Rotarix, dose 2</description>
          </group>
        </group_list>
        <measure>
          <title>Number (or Percentage) of Infants in Each Study Arm With Rotavirus-specific Plasma Immunoglobulin A (IgA) Seroconversion Post-vaccination</title>
          <description>This outcome will measure seroconversion, i.e. the change in plasma rotavirus-specific IgA concentration at week 14 of life compared to week 6 of life (baseline). Blood will be collected from infants prior to the first dose of Rotarix at week 6 of life and again at week 14 of life (4 weeks following the second dose) for measurement of plasma rotavirus-specific IgA by enzyme immunoassay. Infants will be assessed for seroconversion (IgA concentration &lt;=20 U/mL pre-vaccination and &gt;20 post-vaccination). Infants who demonstrate rotavirus-specific IgA seroconversion will be categorized as having met the outcome measure.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number (or Percentage) of Infants in Each Study Arm With Successful Vaccine Take, Defined as Positive Fecal Vaccine Shedding Post-vaccination OR Rotavirus-specific Plasma IgA Seroconversion Post-vaccination</title>
        <description>Vaccine take is an aggregate, dichotomous immunogenicity measure (successful vaccine take vs no vaccine take). Infants positive for either fecal vaccine shedding OR plasma rotavirus-specific IgA seroconversion (as described in Outcomes 1 and 2, respectively) will be categorized as having met the outcome measure of successful vaccine take. Those who met neither outcome will be categorized as no vaccine take.</description>
        <time_frame>Measured at week 14 of life</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Rotarix, Single Dose</title>
            <description>Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life&#xD;
Rotarix, dose 1: Rotarix, dose 1&#xD;
Placebo (for Rotarix dose 2): Sterile water to provide volume equivalent as a second dose of Rotarix</description>
          </group>
          <group group_id="O2">
            <title>Rotarix, Double Dose</title>
            <description>Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life&#xD;
Rotarix, dose 1: Rotarix, dose 1&#xD;
Rotarix, dose 2: Rotarix, dose 2</description>
          </group>
        </group_list>
        <measure>
          <title>Number (or Percentage) of Infants in Each Study Arm With Successful Vaccine Take, Defined as Positive Fecal Vaccine Shedding Post-vaccination OR Rotavirus-specific Plasma IgA Seroconversion Post-vaccination</title>
          <description>Vaccine take is an aggregate, dichotomous immunogenicity measure (successful vaccine take vs no vaccine take). Infants positive for either fecal vaccine shedding OR plasma rotavirus-specific IgA seroconversion (as described in Outcomes 1 and 2, respectively) will be categorized as having met the outcome measure of successful vaccine take. Those who met neither outcome will be categorized as no vaccine take.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                    <measurement group_id="O2" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Enrollment (&lt;7 days of life) through week 14 study visit (4 months) for serious adverse events; week 6 visit (first vaccine dose) through Week 14 visit + 3 days (end of participation) for all other AEs (2 months)</time_frame>
      <desc>Serious adverse events were recorded from study enrollment (&lt;7 days of life) but all other adverse events were only recorded starting from the first study intervention (at the week 6 clinic visit), the total numbers of children evaluated for serious adverse events (which is based on study enrollment) differs from those evaluated for adverse events (which is based on the number of children dosed starting at week 6 of life, and is less due to attrition between enrollment and first dosing).</desc>
      <group_list>
        <group group_id="E1">
          <title>Rotarix, Single Dose</title>
          <description>Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life&#xD;
Rotarix, dose 1: Rotarix, dose 1&#xD;
Placebo (for Rotarix dose 2): Sterile water to provide volume equivalent as a second dose of Rotarix</description>
        </group>
        <group group_id="E2">
          <title>Rotarix, Double Dose</title>
          <description>Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life&#xD;
Rotarix, dose 1: Rotarix, dose 1&#xD;
Rotarix, dose 2: Rotarix, dose 2</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-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="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>Subacute intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diaphragmatic hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="28" subjects_at_risk="107"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="20" subjects_affected="18" subjects_at_risk="107"/>
                <counts group_id="E2" events="17" subjects_affected="16" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Gastroenteritis (vomiting and/or diarrhea)</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="21" subjects_affected="19" subjects_at_risk="107"/>
                <counts group_id="E2" events="21" subjects_affected="18" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="24" subjects_affected="22" subjects_at_risk="107"/>
                <counts group_id="E2" events="24" subjects_affected="21" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough or runny nose</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="107"/>
                <counts group_id="E2" events="19" subjects_affected="18" subjects_at_risk="106"/>
              </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>Benjamin Lee</name_or_title>
      <organization>The University of Vermont College of Medicine</organization>
      <phone>8026567748</phone>
      <email>blee7@uvm.edu</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/NCT02992197
org study id: CHRMS 17-0166
nct id: NCT02992197
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Rotavirus is the leading cause of diarrhea in children worldwide. Oral rotavirus vaccines
      work remarkably well in high-income countries, but for unclear reasons they underperform in
      low-income countries. A double-blind, randomized control trial will be performed to evaluate
      whether using a higher dose of a currently licensed vaccine (Rotarix, GlaxoSmithKline) can
      improve immune responses among infants in Dhaka, Bangladesh.

      Infants will be randomized 1:1 to receive either a standard or a double dose of Rotarix at 6
      and 10 weeks of life. Infants will be assessed for fecal vaccine shedding and serum
      rotavirus-specific IgA responses to determine vaccine immunogenicity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number (or Percentage) of Infants in Each Study Arm Who Test Positive for Fecal Rotavirus Vaccine-strain Virus Shedding Post-vaccination
time frame: Measured through week 12 of life
description: This will be an aggregate measure demonstrating a change from baseline. Infants will have stool collected immediately prior to Rotarix vaccination at weeks 6 and 10 of life, then 4, 7, and 14 days following each dose (i.e. last assessment at week 12 of life). Each specimen will be assessed for vaccine-strain virus (i.e. fecal vaccine shedding) at each time point by polymerase chain reaction. Any child who has a change in fecal vaccine shedding status, from negative at baseline (6 weeks) to positive at any subsequent time point, will be categorized as having met the outcome measure for positive fecal vaccine shedding.
measure: Number (or Percentage) of Infants in Each Study Arm With Rotavirus-specific Plasma Immunoglobulin A (IgA) Seroconversion Post-vaccination
time frame: Measured at week 14 of life
description: This outcome will measure seroconversion, i.e. the change in plasma rotavirus-specific IgA concentration at week 14 of life compared to week 6 of life (baseline). Blood will be collected from infants prior to the first dose of Rotarix at week 6 of life and again at week 14 of life (4 weeks following the second dose) for measurement of plasma rotavirus-specific IgA by enzyme immunoassay. Infants will be assessed for seroconversion (IgA concentration <=20 U/mL pre-vaccination and >20 post-vaccination). Infants who demonstrate rotavirus-specific IgA seroconversion will be categorized as having met the outcome measure.
measure: Number (or Percentage) of Infants in Each Study Arm With Successful Vaccine Take, Defined as Positive Fecal Vaccine Shedding Post-vaccination OR Rotavirus-specific Plasma IgA Seroconversion Post-vaccination
time frame: Measured at week 14 of life
description: Vaccine take is an aggregate, dichotomous immunogenicity measure (successful vaccine take vs no vaccine take). Infants positive for either fecal vaccine shedding OR plasma rotavirus-specific IgA seroconversion (as described in Outcomes 1 and 2, respectively) will be categorized as having met the outcome measure of successful vaccine take. Those who met neither outcome will be categorized as no vaccine take.
arm group label: Rotarix, single dose
arm group type: Active Comparator
description: Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life
arm group label: Rotarix, double dose
arm group type: Experimental
description: Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life
intervention type: Biological
intervention name: Rotarix, dose 1
description: Rotarix, dose 1
arm group label: Rotarix, double dose
arm group label: Rotarix, single dose
intervention type: Biological
intervention name: Rotarix, dose 2
description: Rotarix, dose 2
arm group label: Rotarix, double dose
intervention type: Drug
intervention name: Placebo (for Rotarix dose 2)
description: Sterile water to provide volume equivalent as a second dose of Rotarix
arm group label: Rotarix, single dose
criteria: 
gender: All
minimum age: N/A
maximum age: 15 Weeks
healthy volunteers: Accepts Healthy Volunteers
last name: Benjamin Lee, M.D.
role: Principal Investigator
affiliation: University of Vermont
facility: 
country: Bangladesh
responsible party type: Principal Investigator
investigator affiliation: University of Vermont
investigator full name: Benjamin Lee
investigator title: Assistant Professor, Department of Pediatrics
mesh term: Rotavirus Infections
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 