<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/NCT01700621</url>
  </required_header>
  <id_info>
    <org_study_id>HS677</org_study_id>
    <nct_id>NCT01700621</nct_id>
  </id_info>
  <brief_title>Coadministration of Measles-rubella and Rotavirus Vaccines</brief_title>
  <official_title>Non-interference and Safety of Concomitant Administration of Measles-rubella and Rotavirus Vaccines at 9 Months of Age in Rural Bangladesh</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PATH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PATH</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim to establish the non-inferiority of concomitant administration of&#xD;
      measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of&#xD;
      measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate&#xD;
      as defined by the percentage of children seroconverting to measles with a measles serum&#xD;
      antibody concentration of &gt;=1:120 at 8 weeks post vaccination after the concomitant&#xD;
      administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained&#xD;
      when measles-rubella vaccine is given alone in children 9 months of age who have received a&#xD;
      primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at&#xD;
      least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies</measure>
    <time_frame>8 weeks post vaccination</time_frame>
    <description>Detected by plaque reduction neutralization test (PRNT).&#xD;
Seroprotection defined as measles serum antibody concentration &gt;=1:120 8 weeks post vaccination. Assays were standardized using WHO Second International Standard for measles antibody containing 5000 mIU/ml, which enables the 50% neutralizing antibody end-point dose (titer, ND50) of test samples to be transformed to antibody concentrations in terms of mIU/ml. The analytical cut-off value in this assay was ND50 &lt; 1/8; this was the lowest dilution at which sera were tested.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG)</measure>
    <time_frame>8 weeks post vaccination</time_frame>
    <description>Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for measles virus. All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage/Number of Subjects With Seroconversion for Anti-rubella Virus Immunoglobulin G (IgG)</measure>
    <time_frame>8 weeks post vaccination</time_frame>
    <description>Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for rubella virus. An ISR of at least 1.10 represents 10 IU/mL of rubella virus antibody, consistent with a protective level.All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Concentration (GMC) for Anti-rubella Virus Immunoglobulin G (IgG)</measure>
    <time_frame>8 weeks post vaccination</time_frame>
    <description>Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for rubella virus. An ISR of at least 1.10 represents 10 IU/mL of rubella virus antibody, consistent with a protective level.All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin A (IgA)</measure>
    <time_frame>Visit 1 (pre-vaccination) and 8 weeks post vaccination</time_frame>
    <description>Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin A (IgA)</measure>
    <time_frame>Visit 1 (pre-vaccination) and 8 weeks post vaccination</time_frame>
    <description>Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. Rotavirus IgA and IgG values of &lt;20 U/mL are converted to 10 U/mL for calculation purposes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin G (IgG)</measure>
    <time_frame>Visit 1 (pre-vaccination) and 8 weeks post vaccination</time_frame>
    <description>Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin G (IgG)</measure>
    <time_frame>Visit 1 (pre-vaccination) and 8 weeks post vaccination</time_frame>
    <description>Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. Rotavirus IgA and IgG values of &lt;20 U/mL are converted to 10 U/mL for calculation purposes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin A (IgA)</measure>
    <time_frame>8 weeks post vaccination</time_frame>
    <description>Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin G (IgG)</measure>
    <time_frame>8 weeks post vaccination</time_frame>
    <description>Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number/Percentage of Subjects Experiencing Immediate Post-vaccination Reactions Following Administration of Vaccine</measure>
    <time_frame>30 minutes post-vaccination</time_frame>
    <description>Immediate reactogenicity was defined as local or systemic reactions occurring directly and up to 30 minutes after vaccine receipt, with an emphasis on allergic reactions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number/Percentage of Subjects Experiencing Solicited Adverse Events</measure>
    <time_frame>14 days post-vaccination</time_frame>
    <description>Solicited non-serious adverse events were collected based on recall at study visits 2 (Day 4) through 5 (Day 14) following administration of Rotarix® vaccine. They included diarrhea, fever, vomiting, loss of appetite, irritability, and intussusception. Adverse events were graded for severity and relationship to vaccine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number/Percentage of Subjects Experiencing Unsolicited Non-serious Adverse Events</measure>
    <time_frame>14 days post-vaccination</time_frame>
    <description>Solicited non-serious adverse events were collected based on recall at study visits 2 (Day 4) through 5 (Day 14) following administration of Rotarix® vaccine. Adverse events were graded for severity and relationship to vaccine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number/Percentage of Subjects Experiencing Serious Adverse Events</measure>
    <time_frame>2 months after vaccination</time_frame>
    <description>An adverse event (AE) or suspected AE was considered &quot;serious&quot; if it resulted in any of the following outcomes:&#xD;
Death&#xD;
A life-threatening AE (the term &quot;life-threatening&quot; in the definition of &quot;serious&quot; refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe)&#xD;
Inpatient hospitalization or prolongation of existing hospitalization&#xD;
A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions&#xD;
Important medical events that may not result in death, be life threatening, or require hospitalization would have been considered severe adverse events when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Geometric Mean Concentration (GMC) for Measles Virus Serum Neutralization Antibodies</measure>
    <time_frame>8 weeks post vaccination</time_frame>
    <description>Sera were analyzed for the presence of measles virus serum neutralizing antibodies (SNAs), using a standardized plaque reduction neutralization (PRN) assay, in which PRN titers, defined as the serum dilutions that reduced the number of plaques by 50%, were calculated using the Kärber method [12]. A 1:100 dilution of World Health Organization (WHO) Second International Standard Anti-Measles Serum (IS, coded 66/202, supplied by the National Institute for Biological Standards and Control, South Mimms, United Kingdom) was tested in parallel with each serum specimen to calculate the reciprocal of the 50% end point titer determined by the PRN test.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Rotavirus Vaccine Shedding</measure>
    <time_frame>Day 0, Day 4 and Day 7</time_frame>
    <description>Based on 5 grams of stool sample. Vaccine shedding defined as presence of vaccine-type rotavirus in stool at 4 (+/-1) and/or 7 (+/-1) days post rotavirus vaccination detected by enzyme-linked immunosorbent assay (ELISA) and typed by reverse-transcriptase polymerase chain reaction (RT-PCR).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">482</enrollment>
  <condition>Measles Antibody Seroconversion</condition>
  <condition>Rubella Antibody Seroconversion</condition>
  <condition>Rotavirus Geometric Mean Titer (GMT)</condition>
  <condition>Rotavirus Immunoglobulin A (IgA) Seropositivity</condition>
  <arm_group>
    <arm_group_label>measles-rubella and rotavirus vaccines</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age</description>
  </arm_group>
  <arm_group>
    <arm_group_label>measles-rubella vaccine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Rotarix vaccine</intervention_name>
    <description>one 1.0 ml dose of oral rotavirus vaccine at 9 months of age</description>
    <arm_group_label>measles-rubella and rotavirus vaccines</arm_group_label>
    <other_name>rotavirus vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>measles-rubella vaccine</intervention_name>
    <description>one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
    <arm_group_label>measles-rubella and rotavirus vaccines</arm_group_label>
    <arm_group_label>measles-rubella vaccine</arm_group_label>
    <other_name>Measles-Rubella Virus Vaccine Live US Pharmacopeia (USP)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child 9 months of age eligible for measles-rubella vaccination&#xD;
&#xD;
          -  documented evidence of a primary rotavirus vaccine series with first dose between 6&#xD;
             and 10 weeks of age and second dose at least 4 weeks after first dose&#xD;
&#xD;
          -  healthy infants free of chronic or serious medical condition as determined by history&#xD;
             and physical examination at time of study enrollment&#xD;
&#xD;
          -  parents/guardians of each participant are able to understand and follow study&#xD;
             procedures and agree to participate in study by providing signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hypersensitivity to any component of measles-rubella or Rotarix vaccine which would&#xD;
             preclude administration of the vaccine&#xD;
&#xD;
          -  history of intussusception, intestinal malformations, or abdominal surgery&#xD;
&#xD;
          -  known history of measles and/or rubella disease&#xD;
&#xD;
          -  history of previous receipt of measles and/or rubella vaccine&#xD;
&#xD;
          -  use of any immunosuppressive drugs or immunoglobulin and/or blood products since birth&#xD;
             or anticipated during study period&#xD;
&#xD;
          -  current enrolment in any other intervention trial or use of any investigational drug&#xD;
             or vaccine throughout the study period&#xD;
&#xD;
          -  any participant who reports planning to leave the study area before the completion of&#xD;
             the study&#xD;
&#xD;
          -  acute diarrhea (defined as ≥3 loose stools within a 24-hour period) or vomiting&#xD;
             (defined as projectile vomiting or any vomiting at the discretion of the clinician) at&#xD;
             the time of enrollment or within the last 24 hours&#xD;
&#xD;
          -  acute febrile illness (defined as a temperature of ≥38°C) at the time of enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Months</minimum_age>
    <maximum_age>11 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>K Zaman, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Centre for Diarrhoeal Disease Research, Bangladesh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ICDDR,B</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>May 29, 2018</results_first_submitted>
  <results_first_submitted_qc>February 14, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">February 18, 2019</results_first_posted>
  <last_update_submitted>February 15, 2019</last_update_submitted>
  <last_update_submitted_qc>February 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rotavirus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Measles</mesh_term>
    <mesh_term>Rubella</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study population was drawn from participants living in the International Center for Diarrheal Disease Research, Bangladesh (icddr,b) service area of Matlab, Bangladesh.</recruitment_details>
      <pre_assignment_details>Recruitment concurrently conducted at a number of health sites in the study area, which resulted in two additional infants being enrolled but subsequently not vaccinated with withdrawn from the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Measles-rubella and Rotavirus Vaccines</title>
          <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
        </group>
        <group group_id="P2">
          <title>Measles-rubella Vaccine</title>
          <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Received Study Vaccines</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="240"/>
                <participants group_id="P2" count="240"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="240"/>
                <participants group_id="P2" count="240"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Analyzed for Immunogenicity</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="240"/>
                <participants group_id="P2" count="240"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="227"/>
                <participants group_id="P2" count="233"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Baseline measles measure high</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Measles-rubella and Rotavirus Vaccines</title>
          <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
        </group>
        <group group_id="B2">
          <title>Measles-rubella Vaccine</title>
          <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</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="240"/>
            <count group_id="B2" value="240"/>
            <count group_id="B3" value="480"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.38" spread="0.252"/>
                    <measurement group_id="B2" value="9.39" spread="0.254"/>
                    <measurement group_id="B3" value="9.38" spread="0.253"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                    <measurement group_id="B2" value="123"/>
                    <measurement group_id="B3" value="233"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="117"/>
                    <measurement group_id="B3" value="247"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Currently breastfed</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="236"/>
                    <measurement group_id="B2" value="238"/>
                    <measurement group_id="B3" value="474"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <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_list>
        </measure>
        <measure>
          <title>Length</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.56" spread="2.488"/>
                    <measurement group_id="B2" value="69.81" spread="2.786"/>
                    <measurement group_id="B3" value="69.68" spread="2.642"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.01" spread="1.101"/>
                    <measurement group_id="B2" value="7.97" spread="0.933"/>
                    <measurement group_id="B3" value="7.99" spread="1.047"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mother's age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.1" spread="5.84"/>
                    <measurement group_id="B2" value="26.7" spread="5.90"/>
                    <measurement group_id="B3" value="26.9" spread="5.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies</title>
        <description>Detected by plaque reduction neutralization test (PRNT).&#xD;
Seroprotection defined as measles serum antibody concentration &gt;=1:120 8 weeks post vaccination. Assays were standardized using WHO Second International Standard for measles antibody containing 5000 mIU/ml, which enables the 50% neutralizing antibody end-point dose (titer, ND50) of test samples to be transformed to antibody concentrations in terms of mIU/ml. The analytical cut-off value in this assay was ND50 &lt; 1/8; this was the lowest dilution at which sera were tested.</description>
        <time_frame>8 weeks post vaccination</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Measles-rubella and Rotavirus Vaccines</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
          <group group_id="O2">
            <title>Measles-rubella Vaccine</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies</title>
          <description>Detected by plaque reduction neutralization test (PRNT).&#xD;
Seroprotection defined as measles serum antibody concentration &gt;=1:120 8 weeks post vaccination. Assays were standardized using WHO Second International Standard for measles antibody containing 5000 mIU/ml, which enables the 50% neutralizing antibody end-point dose (titer, ND50) of test samples to be transformed to antibody concentrations in terms of mIU/ml. The analytical cut-off value in this assay was ND50 &lt; 1/8; this was the lowest dilution at which sera were tested.</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="227"/>
                <count group_id="O2" value="233"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Seroprotection</title>
                  <measurement_list>
                    <measurement group_id="O1" value="171"/>
                    <measurement group_id="O2" value="173"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No seroprotection</title>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>A noninferiority margin of -10% was chosen as the maximal absolute reduction in proportion seroprotection allowed in the concomitant measles-rubella and rotavirus vaccine group as compared to the measles-rubella vaccine alone group.</non_inferiority_desc>
            <param_type>Seroconversion proportion difference</param_type>
            <param_value>1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.9</ci_lower_limit>
            <ci_upper_limit>9.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG)</title>
        <description>Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for measles virus. All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).</description>
        <time_frame>8 weeks post vaccination</time_frame>
        <population>All children meeting inclusion/exclusion criteria with a valid sample.</population>
        <group_list>
          <group group_id="O1">
            <title>Measles-rubella and Rotavirus Vaccines</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
          <group group_id="O2">
            <title>Measles-rubella Vaccine</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG)</title>
          <description>Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for measles virus. All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).</description>
          <population>All children meeting inclusion/exclusion criteria with a valid sample.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="232"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Seroprotection</title>
                  <measurement_list>
                    <measurement group_id="O1" value="219"/>
                    <measurement group_id="O2" value="227"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No seroprotection</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage/Number of Subjects With Seroconversion for Anti-rubella Virus Immunoglobulin G (IgG)</title>
        <description>Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for rubella virus. An ISR of at least 1.10 represents 10 IU/mL of rubella virus antibody, consistent with a protective level.All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).</description>
        <time_frame>8 weeks post vaccination</time_frame>
        <population>All children meeting inclusion and exclusion criteria with valid samples.</population>
        <group_list>
          <group group_id="O1">
            <title>Measles-rubella and Rotavirus Vaccines</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
          <group group_id="O2">
            <title>Measles-rubella Vaccine</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage/Number of Subjects With Seroconversion for Anti-rubella Virus Immunoglobulin G (IgG)</title>
          <description>Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for rubella virus. An ISR of at least 1.10 represents 10 IU/mL of rubella virus antibody, consistent with a protective level.All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).</description>
          <population>All children meeting inclusion and exclusion criteria with valid samples.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="228"/>
                <count group_id="O2" value="234"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Seroprotection</title>
                  <measurement_list>
                    <measurement group_id="O1" value="228"/>
                    <measurement group_id="O2" value="233"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No seroprotection</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Concentration (GMC) for Anti-rubella Virus Immunoglobulin G (IgG)</title>
        <description>Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for rubella virus. An ISR of at least 1.10 represents 10 IU/mL of rubella virus antibody, consistent with a protective level.All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).</description>
        <time_frame>8 weeks post vaccination</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Measles-rubella and Rotavirus Vaccines</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
          <group group_id="O2">
            <title>Measles-rubella Vaccine</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Concentration (GMC) for Anti-rubella Virus Immunoglobulin G (IgG)</title>
          <description>Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for rubella virus. An ISR of at least 1.10 represents 10 IU/mL of rubella virus antibody, consistent with a protective level.All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).</description>
          <units>IU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="228"/>
                <count group_id="O2" value="234"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="191.9" lower_limit="174.8" upper_limit="210.7"/>
                    <measurement group_id="O2" value="177.8" lower_limit="161.8" upper_limit="195.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin A (IgA)</title>
        <description>Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.</description>
        <time_frame>Visit 1 (pre-vaccination) and 8 weeks post vaccination</time_frame>
        <population>All participants meeting inclusion/exclusion criteria and with valid samples.</population>
        <group_list>
          <group group_id="O1">
            <title>Measles-rubella and Rotavirus Vaccine</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
          <group group_id="O2">
            <title>Measles-rubella Vaccine</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin A (IgA)</title>
          <description>Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.</description>
          <population>All participants meeting inclusion/exclusion criteria and with valid samples.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="239"/>
                <count group_id="O2" value="240"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="239"/>
                    <count group_id="O2" value="240"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Seropositive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="126"/>
                    <measurement group_id="O2" value="113"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not seropositive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="113"/>
                    <measurement group_id="O2" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="230"/>
                    <count group_id="O2" value="240"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Seropositive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="160"/>
                    <measurement group_id="O2" value="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not seropositive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin A (IgA)</title>
        <description>Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. Rotavirus IgA and IgG values of &lt;20 U/mL are converted to 10 U/mL for calculation purposes.</description>
        <time_frame>Visit 1 (pre-vaccination) and 8 weeks post vaccination</time_frame>
        <population>All participants meeting inclusion/exclusion criteria and with valid samples.</population>
        <group_list>
          <group group_id="O1">
            <title>Measles-rubella and Rotavirus Vaccines</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
          <group group_id="O2">
            <title>Measles-rubella Vaccine</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin A (IgA)</title>
          <description>Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. Rotavirus IgA and IgG values of &lt;20 U/mL are converted to 10 U/mL for calculation purposes.</description>
          <population>All participants meeting inclusion/exclusion criteria and with valid samples.</population>
          <units>U/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="239"/>
                <count group_id="O2" value="240"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.6" lower_limit="34.8" upper_limit="54.5"/>
                    <measurement group_id="O2" value="39.2" lower_limit="31.3" upper_limit="49.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.6" lower_limit="49.4" upper_limit="74.2"/>
                    <measurement group_id="O2" value="38.1" lower_limit="30.5" upper_limit="47.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin G (IgG)</title>
        <description>Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.</description>
        <time_frame>Visit 1 (pre-vaccination) and 8 weeks post vaccination</time_frame>
        <population>All participants meeting inclusion/exclusion criteria and with valid samples.</population>
        <group_list>
          <group group_id="O1">
            <title>Measles-rubella and Rotavirus Vaccines</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
          <group group_id="O2">
            <title>Measles-rubella Vaccine</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin G (IgG)</title>
          <description>Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.</description>
          <population>All participants meeting inclusion/exclusion criteria and with valid samples.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="240"/>
                <count group_id="O2" value="240"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="240"/>
                    <count group_id="O2" value="240"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Seropositive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="159"/>
                    <measurement group_id="O2" value="140"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not seropositive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="81"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="236"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Seropositive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="204"/>
                    <measurement group_id="O2" value="135"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not seropositive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin G (IgG)</title>
        <description>Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. Rotavirus IgA and IgG values of &lt;20 U/mL are converted to 10 U/mL for calculation purposes.</description>
        <time_frame>Visit 1 (pre-vaccination) and 8 weeks post vaccination</time_frame>
        <population>All participants meeting inclusion/exclusion criteria and with valid samples.</population>
        <group_list>
          <group group_id="O1">
            <title>Measles-rubella and Rotavirus Vaccines</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
          <group group_id="O2">
            <title>Measles-rubella Vaccine</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin G (IgG)</title>
          <description>Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. Rotavirus IgA and IgG values of &lt;20 U/mL are converted to 10 U/mL for calculation purposes.</description>
          <population>All participants meeting inclusion/exclusion criteria and with valid samples.</population>
          <units>U/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="240"/>
                <count group_id="O2" value="240"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.2" lower_limit="61.4" upper_limit="102.1"/>
                    <measurement group_id="O2" value="63.2" lower_limit="49.1" upper_limit="81.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168.6" lower_limit="137.3" upper_limit="207.2"/>
                    <measurement group_id="O2" value="60.1" lower_limit="46.7" upper_limit="77.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin A (IgA)</title>
        <description>Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.</description>
        <time_frame>8 weeks post vaccination</time_frame>
        <population>All subjects that met inclusion and exclusion criteria with valid samples and were not seropositive prior to the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Measles-rubella and Rotavirus Vaccines</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
          <group group_id="O2">
            <title>Measles-rubella Vaccine</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin A (IgA)</title>
          <description>Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.</description>
          <population>All subjects that met inclusion and exclusion criteria with valid samples and were not seropositive prior to the intervention</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="126"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Seroconversion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No seroconversion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin G (IgG)</title>
        <description>Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.</description>
        <time_frame>8 weeks post vaccination</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Measles-rubella and Rotavirus Vaccines</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
          <group group_id="O2">
            <title>Measles-rubella Vaccine</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin G (IgG)</title>
          <description>Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.</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="80"/>
                <count group_id="O2" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Seroconversion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No seroconversion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number/Percentage of Subjects Experiencing Immediate Post-vaccination Reactions Following Administration of Vaccine</title>
        <description>Immediate reactogenicity was defined as local or systemic reactions occurring directly and up to 30 minutes after vaccine receipt, with an emphasis on allergic reactions.</description>
        <time_frame>30 minutes post-vaccination</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Measles-rubella and Rotavirus Vaccines</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
          <group group_id="O2">
            <title>Measles-rubella Vaccine</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Number/Percentage of Subjects Experiencing Immediate Post-vaccination Reactions Following Administration of Vaccine</title>
          <description>Immediate reactogenicity was defined as local or systemic reactions occurring directly and up to 30 minutes after vaccine receipt, with an emphasis on allergic reactions.</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="240"/>
                <count group_id="O2" value="240"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Any immediate reaction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No immediate reaction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="240"/>
                    <measurement group_id="O2" value="240"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number/Percentage of Subjects Experiencing Solicited Adverse Events</title>
        <description>Solicited non-serious adverse events were collected based on recall at study visits 2 (Day 4) through 5 (Day 14) following administration of Rotarix® vaccine. They included diarrhea, fever, vomiting, loss of appetite, irritability, and intussusception. Adverse events were graded for severity and relationship to vaccine.</description>
        <time_frame>14 days post-vaccination</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Measles-rubella and Rotavirus Vaccines</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
          <group group_id="O2">
            <title>Measles-rubella Vaccine</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Number/Percentage of Subjects Experiencing Solicited Adverse Events</title>
          <description>Solicited non-serious adverse events were collected based on recall at study visits 2 (Day 4) through 5 (Day 14) following administration of Rotarix® vaccine. They included diarrhea, fever, vomiting, loss of appetite, irritability, and intussusception. Adverse events were graded for severity and relationship to vaccine.</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="240"/>
                <count group_id="O2" value="240"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 1: unrelated to vaccine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2: unrelated to vaccine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3: unrelated to vaccine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="209"/>
                    <measurement group_id="O2" value="202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number/Percentage of Subjects Experiencing Unsolicited Non-serious Adverse Events</title>
        <description>Solicited non-serious adverse events were collected based on recall at study visits 2 (Day 4) through 5 (Day 14) following administration of Rotarix® vaccine. Adverse events were graded for severity and relationship to vaccine.</description>
        <time_frame>14 days post-vaccination</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Measles-rubella and Rotavirus Vaccines</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
          <group group_id="O2">
            <title>Measles-rubella Vaccine</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Number/Percentage of Subjects Experiencing Unsolicited Non-serious Adverse Events</title>
          <description>Solicited non-serious adverse events were collected based on recall at study visits 2 (Day 4) through 5 (Day 14) following administration of Rotarix® vaccine. Adverse events were graded for severity and relationship to vaccine.</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="240"/>
                <count group_id="O2" value="240"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Related to vaccine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unrelated to vaccine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No unsolicited non-serious adverse event</title>
                  <measurement_list>
                    <measurement group_id="O1" value="177"/>
                    <measurement group_id="O2" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number/Percentage of Subjects Experiencing Serious Adverse Events</title>
        <description>An adverse event (AE) or suspected AE was considered &quot;serious&quot; if it resulted in any of the following outcomes:&#xD;
Death&#xD;
A life-threatening AE (the term &quot;life-threatening&quot; in the definition of &quot;serious&quot; refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe)&#xD;
Inpatient hospitalization or prolongation of existing hospitalization&#xD;
A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions&#xD;
Important medical events that may not result in death, be life threatening, or require hospitalization would have been considered severe adverse events when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition.</description>
        <time_frame>2 months after vaccination</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Measles-rubella and Rotavirus Vaccines</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
          <group group_id="O2">
            <title>Measles-rubella Vaccine</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Number/Percentage of Subjects Experiencing Serious Adverse Events</title>
          <description>An adverse event (AE) or suspected AE was considered &quot;serious&quot; if it resulted in any of the following outcomes:&#xD;
Death&#xD;
A life-threatening AE (the term &quot;life-threatening&quot; in the definition of &quot;serious&quot; refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe)&#xD;
Inpatient hospitalization or prolongation of existing hospitalization&#xD;
A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions&#xD;
Important medical events that may not result in death, be life threatening, or require hospitalization would have been considered severe adverse events when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition.</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="240"/>
                <count group_id="O2" value="240"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Any serious adverse event, unrelated to vaccine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No serious adverse event</title>
                  <measurement_list>
                    <measurement group_id="O1" value="230"/>
                    <measurement group_id="O2" value="234"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Geometric Mean Concentration (GMC) for Measles Virus Serum Neutralization Antibodies</title>
        <description>Sera were analyzed for the presence of measles virus serum neutralizing antibodies (SNAs), using a standardized plaque reduction neutralization (PRN) assay, in which PRN titers, defined as the serum dilutions that reduced the number of plaques by 50%, were calculated using the Kärber method [12]. A 1:100 dilution of World Health Organization (WHO) Second International Standard Anti-Measles Serum (IS, coded 66/202, supplied by the National Institute for Biological Standards and Control, South Mimms, United Kingdom) was tested in parallel with each serum specimen to calculate the reciprocal of the 50% end point titer determined by the PRN test.</description>
        <time_frame>8 weeks post vaccination</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Measles-rubella and Rotavirus Vaccines</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
          <group group_id="O2">
            <title>Measles-rubella Vaccine</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Concentration (GMC) for Measles Virus Serum Neutralization Antibodies</title>
          <description>Sera were analyzed for the presence of measles virus serum neutralizing antibodies (SNAs), using a standardized plaque reduction neutralization (PRN) assay, in which PRN titers, defined as the serum dilutions that reduced the number of plaques by 50%, were calculated using the Kärber method [12]. A 1:100 dilution of World Health Organization (WHO) Second International Standard Anti-Measles Serum (IS, coded 66/202, supplied by the National Institute for Biological Standards and Control, South Mimms, United Kingdom) was tested in parallel with each serum specimen to calculate the reciprocal of the 50% end point titer determined by the PRN test.</description>
          <units>mIU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="233"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="196.3" lower_limit="175.3" upper_limit="219.7"/>
                    <measurement group_id="O2" value="194.2" lower_limit="174.0" upper_limit="216.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Rotavirus Vaccine Shedding</title>
        <description>Based on 5 grams of stool sample. Vaccine shedding defined as presence of vaccine-type rotavirus in stool at 4 (+/-1) and/or 7 (+/-1) days post rotavirus vaccination detected by enzyme-linked immunosorbent assay (ELISA) and typed by reverse-transcriptase polymerase chain reaction (RT-PCR).</description>
        <time_frame>Day 0, Day 4 and Day 7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Measles-rubella and Rotavirus Vaccines</title>
            <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Rotavirus Vaccine Shedding</title>
          <description>Based on 5 grams of stool sample. Vaccine shedding defined as presence of vaccine-type rotavirus in stool at 4 (+/-1) and/or 7 (+/-1) days post rotavirus vaccination detected by enzyme-linked immunosorbent assay (ELISA) and typed by reverse-transcriptase polymerase chain reaction (RT-PCR).</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="240"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0</title>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="140"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No stool</title>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4</title>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="234"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No stool</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="234"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No stool</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 months after vaccination</time_frame>
      <desc>Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or &quot;red currant jelly,&quot; and/or vomiting ≥2 episodes/day).</desc>
      <group_list>
        <group group_id="E1">
          <title>Measles-rubella and Rotavirus Vaccines</title>
          <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age&#xD;
Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
        </group>
        <group group_id="E2">
          <title>Measles-rubella Vaccine</title>
          <description>receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age&#xD;
measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>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="240"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="240"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="240"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="240"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute watery diarrhea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="240"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="240"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute bronchiolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="240"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="240"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="240"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="240"/>
              </event>
              <event>
                <sub_title>Pneumonia with UTI</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="240"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="240"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="240"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="240"/>
              </event>
              <event>
                <sub_title>Severe pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="240"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile convulsion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="240"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="240"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="240"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <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="63" subjects_at_risk="240"/>
                <counts group_id="E2" subjects_affected="68" subjects_at_risk="240"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="240"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="240"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="240"/>
              </event>
              <event>
                <sub_title>Dysentery</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="240"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="240"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="240"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="240"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="240"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="240"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="240"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="240"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="240"/>
              </event>
              <event>
                <sub_title>Otitis media chronic</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="240"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="240"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="240"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="240"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="240"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="240"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="240"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="240"/>
              </event>
              <event>
                <sub_title>Varicella</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="240"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="240"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="240"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="240"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="240"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="240"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="240"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="240"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="240"/>
              </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>Jorge Flores</name_or_title>
      <organization>PATH</organization>
      <phone>(202) 822-0033</phone>
      <email>jeflores@path.org</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/NCT01700621
org study id: HS677
nct id: NCT01700621
lead sponsor: 
has dmc: Yes
The investigators aim to establish the non-inferiority of concomitant administration of
      measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of
      measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate
      as defined by the percentage of children seroconverting to measles with a measles serum
      antibody concentration of >=1:120 at 8 weeks post vaccination after the concomitant
      administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained
      when measles-rubella vaccine is given alone in children 9 months of age who have received a
      primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at
      least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies
time frame: 8 weeks post vaccination
description: Detected by plaque reduction neutralization test (PRNT).
Seroprotection defined as measles serum antibody concentration >=1:120 8 weeks post vaccination. Assays were standardized using WHO Second International Standard for measles antibody containing 5000 mIU/ml, which enables the 50% neutralizing antibody end-point dose (titer, ND50) of test samples to be transformed to antibody concentrations in terms of mIU/ml. The analytical cut-off value in this assay was ND50 < 1/8; this was the lowest dilution at which sera were tested.
measure: Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG)
time frame: 8 weeks post vaccination
description: Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for measles virus. All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).
measure: Percentage/Number of Subjects With Seroconversion for Anti-rubella Virus Immunoglobulin G (IgG)
time frame: 8 weeks post vaccination
description: Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for rubella virus. An ISR of at least 1.10 represents 10 IU/mL of rubella virus antibody, consistent with a protective level.All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).
measure: Geometric Mean Concentration (GMC) for Anti-rubella Virus Immunoglobulin G (IgG)
time frame: 8 weeks post vaccination
description: Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for rubella virus. An ISR of at least 1.10 represents 10 IU/mL of rubella virus antibody, consistent with a protective level.All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).
measure: Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin A (IgA)
time frame: Visit 1 (pre-vaccination) and 8 weeks post vaccination
description: Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.
measure: Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin A (IgA)
time frame: Visit 1 (pre-vaccination) and 8 weeks post vaccination
description: Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. Rotavirus IgA and IgG values of <20 U/mL are converted to 10 U/mL for calculation purposes.
measure: Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin G (IgG)
time frame: Visit 1 (pre-vaccination) and 8 weeks post vaccination
description: Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.
measure: Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin G (IgG)
time frame: Visit 1 (pre-vaccination) and 8 weeks post vaccination
description: Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. Rotavirus IgA and IgG values of <20 U/mL are converted to 10 U/mL for calculation purposes.
measure: Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin A (IgA)
time frame: 8 weeks post vaccination
description: Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.
measure: Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin G (IgG)
time frame: 8 weeks post vaccination
description: Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.
measure: Number/Percentage of Subjects Experiencing Immediate Post-vaccination Reactions Following Administration of Vaccine
time frame: 30 minutes post-vaccination
description: Immediate reactogenicity was defined as local or systemic reactions occurring directly and up to 30 minutes after vaccine receipt, with an emphasis on allergic reactions.
measure: Number/Percentage of Subjects Experiencing Solicited Adverse Events
time frame: 14 days post-vaccination
description: Solicited non-serious adverse events were collected based on recall at study visits 2 (Day 4) through 5 (Day 14) following administration of Rotarix® vaccine. They included diarrhea, fever, vomiting, loss of appetite, irritability, and intussusception. Adverse events were graded for severity and relationship to vaccine.
measure: Number/Percentage of Subjects Experiencing Unsolicited Non-serious Adverse Events
time frame: 14 days post-vaccination
description: Solicited non-serious adverse events were collected based on recall at study visits 2 (Day 4) through 5 (Day 14) following administration of Rotarix® vaccine. Adverse events were graded for severity and relationship to vaccine.
measure: Number/Percentage of Subjects Experiencing Serious Adverse Events
time frame: 2 months after vaccination
description: An adverse event (AE) or suspected AE was considered "serious" if it resulted in any of the following outcomes:
Death
A life-threatening AE (the term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe)
Inpatient hospitalization or prolongation of existing hospitalization
A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
Important medical events that may not result in death, be life threatening, or require hospitalization would have been considered severe adverse events when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition.
measure: Geometric Mean Concentration (GMC) for Measles Virus Serum Neutralization Antibodies
time frame: 8 weeks post vaccination
description: Sera were analyzed for the presence of measles virus serum neutralizing antibodies (SNAs), using a standardized plaque reduction neutralization (PRN) assay, in which PRN titers, defined as the serum dilutions that reduced the number of plaques by 50%, were calculated using the Kärber method [12]. A 1:100 dilution of World Health Organization (WHO) Second International Standard Anti-Measles Serum (IS, coded 66/202, supplied by the National Institute for Biological Standards and Control, South Mimms, United Kingdom) was tested in parallel with each serum specimen to calculate the reciprocal of the 50% end point titer determined by the PRN test.
measure: Number of Participants With Rotavirus Vaccine Shedding
time frame: Day 0, Day 4 and Day 7
description: Based on 5 grams of stool sample. Vaccine shedding defined as presence of vaccine-type rotavirus in stool at 4 (+/-1) and/or 7 (+/-1) days post rotavirus vaccination detected by enzyme-linked immunosorbent assay (ELISA) and typed by reverse-transcriptase polymerase chain reaction (RT-PCR).
arm group label: measles-rubella and rotavirus vaccines
arm group type: Experimental
description: receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age
arm group label: measles-rubella vaccine
arm group type: Active Comparator
description: receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age
intervention type: Biological
intervention name: Rotarix vaccine
description: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age
arm group label: measles-rubella and rotavirus vaccines
other name: rotavirus vaccine
intervention type: Biological
intervention name: measles-rubella vaccine
description: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
arm group label: measles-rubella and rotavirus vaccines
arm group label: measles-rubella vaccine
other name: Measles-Rubella Virus Vaccine Live US Pharmacopeia (USP)
criteria: 
gender: All
minimum age: 9 Months
maximum age: 11 Months
healthy volunteers: Accepts Healthy Volunteers
last name: K Zaman, PhD, MPH
role: Principal Investigator
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
facility: 
country: Bangladesh
responsible party type: Sponsor
mesh term: Measles
mesh term: Rubella
mesh term: Vaccines
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 