<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/NCT04481191</url>
  </required_header>
  <id_info>
    <org_study_id>V260-074</org_study_id>
    <secondary_id>V260-074</secondary_id>
    <secondary_id>2020-003329-49</secondary_id>
    <nct_id>NCT04481191</nct_id>
  </id_info>
  <brief_title>Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074)</brief_title>
  <official_title>A Phase 3 Randomized, Open-Label, Clinical Trial to Study the Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of V260 and Inactivated Poliomyelitis Vaccine (IPV) in Chinese Healthy Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the immunogenicity and safety of concomitant administration of&#xD;
      RotaTeq® (V260) and inactivated poliomyelitis vaccine (IPV) in Chinese infants. Its primary&#xD;
      objective is to demonstrate that the immunogenicity of IPV in the concomitant-use group is&#xD;
      non-inferior to the immunogenicity of IPV in the staggered-use group. The hypothesis to be&#xD;
      tested is: The seroconversion percentage at 1 month post dose 3 for poliovirus types 1, 2,&#xD;
      and 3 in the concomitant-use group is non-inferior to those of the staggered-use group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 25, 2020</start_date>
  <completion_date type="Actual">May 8, 2021</completion_date>
  <primary_completion_date type="Actual">May 8, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV</measure>
    <time_frame>Baseline and 1 month postdose 3 of IPV (Month ~3.5)</time_frame>
    <description>The immunogenicity of IPV was measured using poliovirus serum neutralizing antibody assay of the National Institutes for Food and Drug Control (NIFDC), Beijing, China. Serum conversion was defined as antibody titer ≥1:8 post-vaccination in baseline seronegative participants or ≥4-fold increase in titer post-vaccination in baseline seropositive participants.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers (GMTs) of Neutralizing Antibody to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV</measure>
    <time_frame>1 month postdose 3 of IPV (Month ~3.5)</time_frame>
    <description>The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:8 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV</measure>
    <time_frame>1 month post dose 3 of IPV (Month ~3.5)</time_frame>
    <description>The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:64 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV</measure>
    <time_frame>1 month postdose 3 of IPV (Month ~3.5)</time_frame>
    <description>The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Solicited Injection-Site Adverse Events</measure>
    <time_frame>Up to 7 days following each IPV vaccination</time_frame>
    <description>Solicited injection-site adverse events (AEs) included erythema, swelling, induration, and pain at the IPV injection-site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Solicited Systemic Adverse Events</measure>
    <time_frame>Up to 7 days following each RotaTeq and/or IPV vaccination</time_frame>
    <description>Solicited systemic AEs included diarrhea, vomiting, and elevated temperature (axillary temperature ≥37.5º C).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to approximately 3.5 months</time_frame>
    <description>The percentage of participants with SAEs is presented. An SAE is an AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or another important medical event.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9</condition>
  <arm_group>
    <arm_group_label>Concomitant RotaTeq and IPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Staggered RotaTeq and IPV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>RotaTeq (V260)</intervention_name>
    <description>Live, pentavalent rotavirus vaccine administered as a 2 mL-dose oral solution</description>
    <arm_group_label>Concomitant RotaTeq and IPV</arm_group_label>
    <arm_group_label>Staggered RotaTeq and IPV</arm_group_label>
    <other_name>RotaTeq</other_name>
    <other_name>V260</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IPV</intervention_name>
    <description>0.5 mL dose IPV (Sabin strain based), administered via IM injection</description>
    <arm_group_label>Concomitant RotaTeq and IPV</arm_group_label>
    <arm_group_label>Staggered RotaTeq and IPV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Chinese infant 48 days to 63 days of age.&#xD;
&#xD;
          -  Infant's legally acceptable representative provides written informed consent for the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of rotavirus disease, congenital gastrointestinal disorders, chronic diarrhea,&#xD;
             failure to thrive, or abdominal surgery.&#xD;
&#xD;
          -  History of intussusception.&#xD;
&#xD;
          -  History of poliomyelitis.&#xD;
&#xD;
          -  Clinical evidence of active gastrointestinal illness. Note: Infants with&#xD;
             gastroesophageal reflux disease [GERD] may participate in the study if the GERD is&#xD;
             well controlled with or without medication.&#xD;
&#xD;
          -  Known or suspected impairment of immunological function, including severe combined&#xD;
             immunodeficiency disease (SCID).&#xD;
&#xD;
          -  Has a fever, with an axillary temperature ≥37.5°C (or equivalent) at the time of&#xD;
             vaccination or within 24 hours prior to vaccination. Note: The Visit 1 may be&#xD;
             rescheduled after complete resolution of febrile illness.&#xD;
&#xD;
          -  Has acute disease.&#xD;
&#xD;
          -  Has underlying diseases such as cardiovascular, renal, liver, or blood disease.&#xD;
&#xD;
          -  History of known hypersensitivity to any components of rotavirus vaccine and/or IPV.&#xD;
&#xD;
          -  Uncontrolled epilepsy, encephalopathy, seizure, or other progressive neurological&#xD;
             diseases.&#xD;
&#xD;
          -  Known thrombocytopenia or any coagulation disorder that would contraindicate&#xD;
             intramuscular injections.&#xD;
&#xD;
          -  Resides in a household with an immunocompromised person, including individuals with&#xD;
             congenital immunodeficiency (including SCID), human immunodeficiency virus (HIV)&#xD;
             infection, leukemia, lymphoma, multiple myeloma, generalized malignance, chronic renal&#xD;
             failure, organ or bone marrow transplantation, or with those receiving&#xD;
             immunosuppressive chemotherapy including long-term systemic corticosteroids.&#xD;
&#xD;
          -  Any condition, which in the opinion of the investigator, may interfere with the&#xD;
             evaluation of the study objectives.&#xD;
&#xD;
          -  Prior administration of any rotavirus vaccines or poliovirus vaccines.&#xD;
&#xD;
          -  Has received inactivated or recombinant vaccines within 14 days prior to Visit 1 or&#xD;
             live vaccines within 28 days prior to Visit 1.&#xD;
&#xD;
          -  Has received an investigational or non-registered product other than study vaccines or&#xD;
             is planning to use such product during the study.&#xD;
&#xD;
          -  Has received immunosuppressive therapies including systemic (intramuscular, oral, or&#xD;
             intravenous) corticosteroids. Note: Participants using non-systemic corticosteroids&#xD;
             (e.g., topical, ophthalmic, and inhaled) are considered eligible for the study.&#xD;
&#xD;
          -  Has received a blood transfusion or blood products, including immunoglobulins or is&#xD;
             planning to receive such product during the study.&#xD;
&#xD;
          -  Has participated in another interventional study prior to Visit 1 or expected to&#xD;
             anytime during the study.&#xD;
&#xD;
          -  The infant's legally acceptable representative is unlikely to adhere to the study&#xD;
             procedures, keep appointments or is planning to permanently relocate from the area&#xD;
             prior to the completion of the study or to leave for an extended period when study&#xD;
             visits would need to be scheduled.&#xD;
&#xD;
          -  Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or&#xD;
             child) who is an investigational site or Sponsor staff member directly involved with&#xD;
             this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>48 Days</minimum_age>
    <maximum_age>63 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yangchun Center For Disease Prevention And Control ( Site 0001)</name>
      <address>
        <city>Yangchun</city>
        <state>Guangdong</state>
        <zip>529600</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <results_first_submitted>January 23, 2023</results_first_submitted>
  <results_first_submitted_qc>January 23, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 17, 2023</results_first_posted>
  <disposition_first_submitted>March 29, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>March 29, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 31, 2022</disposition_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poliomyelitis</mesh_term>
    <mesh_term>Gastroenteritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 1, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT04481191/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>This study was conducted at a study center in China.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Concomitant RotaTeq and IPV</title>
          <description>Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
        </group>
        <group group_id="P2">
          <title>Staggered RotaTeq and IPV</title>
          <description>Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="200"/>
                <participants group_id="P2" count="200"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>≥1 V260 Vaccination</title>
              <participants_list>
                <participants group_id="P1" count="189"/>
                <participants group_id="P2" count="200"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="185"/>
                <participants group_id="P2" count="190"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawn by parent/guardian</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Concomitant RotaTeq and IPV</title>
          <description>Participants will receive RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
        </group>
        <group group_id="B2">
          <title>Staggered RotaTeq and IPV</title>
          <description>Participants will receive RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</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="200"/>
            <count group_id="B2" value="200"/>
            <count group_id="B3" value="400"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.3" spread="4.8"/>
                    <measurement group_id="B2" value="53.3" spread="4.6"/>
                    <measurement group_id="B3" value="53.3" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Infants and toddlers (48 to 63 days)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="200"/>
                    <measurement group_id="B2" value="200"/>
                    <measurement group_id="B3" value="400"/>
                  </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="86"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="179"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="114"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="221"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="200"/>
                    <measurement group_id="B2" value="200"/>
                    <measurement group_id="B3" value="400"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="200"/>
                    <measurement group_id="B2" value="200"/>
                    <measurement group_id="B3" value="400"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV</title>
        <description>The immunogenicity of IPV was measured using poliovirus serum neutralizing antibody assay of the National Institutes for Food and Drug Control (NIFDC), Beijing, China. Serum conversion was defined as antibody titer ≥1:8 post-vaccination in baseline seronegative participants or ≥4-fold increase in titer post-vaccination in baseline seropositive participants.</description>
        <time_frame>Baseline and 1 month postdose 3 of IPV (Month ~3.5)</time_frame>
        <population>Participants who received the 3 scheduled doses of study vaccination, adhered to guidelines for vaccine administration, provided baseline and post-vaccination blood samples within the acceptable day range, and did not have important protocol deviations are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Concomitant RotaTeq and IPV</title>
            <description>Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
          </group>
          <group group_id="O2">
            <title>Staggered RotaTeq and IPV</title>
            <description>Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV</title>
          <description>The immunogenicity of IPV was measured using poliovirus serum neutralizing antibody assay of the National Institutes for Food and Drug Control (NIFDC), Beijing, China. Serum conversion was defined as antibody titer ≥1:8 post-vaccination in baseline seronegative participants or ≥4-fold increase in titer post-vaccination in baseline seropositive participants.</description>
          <population>Participants who received the 3 scheduled doses of study vaccination, adhered to guidelines for vaccine administration, provided baseline and post-vaccination blood samples within the acceptable day range, and did not have important protocol deviations are included.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
                <count group_id="O2" value="187"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Poliovirus Type 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.9"/>
                    <measurement group_id="O2" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poliovirus Type 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.3"/>
                    <measurement group_id="O2" value="99.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poliovirus Type 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="99.5"/>
                  </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>
            <groups_desc>Difference indicates Concomitant-use Group % - Staggered-use Group %</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being &gt; -10 percentage points (one-sided p-value &lt; 0.025).</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <p_value_desc>One-sided p-value</p_value_desc>
            <method>Unstratified Miettinen &amp; Nurminen method</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.0</ci_lower_limit>
            <ci_upper_limit>0.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference indicates Concomitant-use Group % - Staggered-use Group %</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being &gt; -10 percentage points (one-sided p-value &lt; 0.025).</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <p_value_desc>One-sided p-value</p_value_desc>
            <method>Unstratified Miettinen &amp; Nurminen method</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.3</ci_lower_limit>
            <ci_upper_limit>1.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference indicates Concomitant-use % - Staggered-use %</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being &gt; -10 percentage points (one-sided p-value &lt; 0.025).</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <p_value_desc>One-sided p-value</p_value_desc>
            <method>Unstratified Miettinen &amp; Nurminen method</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>3.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers (GMTs) of Neutralizing Antibody to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV</title>
        <description>The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.</description>
        <time_frame>1 month postdose 3 of IPV (Month ~3.5)</time_frame>
        <population>Participants who received the 3 scheduled doses of study vaccination, adhered to guidelines for vaccine administration, provided baseline and post-vaccination blood samples within the acceptable day range, and did not have important protocol deviations are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Concomitant RotaTeq and IPV</title>
            <description>Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
          </group>
          <group group_id="O2">
            <title>Staggered RotaTeq and IPV</title>
            <description>Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMTs) of Neutralizing Antibody to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV</title>
          <description>The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.</description>
          <population>Participants who received the 3 scheduled doses of study vaccination, adhered to guidelines for vaccine administration, provided baseline and post-vaccination blood samples within the acceptable day range, and did not have important protocol deviations are included.</population>
          <units>Titers</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="180"/>
                <count group_id="O2" value="187"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Poliovirus Type 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5600.80" spread="4898.46" lower_limit="4898.46" upper_limit="6403.85"/>
                    <measurement group_id="O2" value="5344.24" spread="4657.51" lower_limit="4657.51" upper_limit="6132.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poliovirus Type 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1059.83" spread="951.13" lower_limit="951.13" upper_limit="1180.96"/>
                    <measurement group_id="O2" value="1122.43" spread="1002.74" lower_limit="1002.74" upper_limit="1256.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poliovirus Type 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3405.56" spread="3033.93" lower_limit="3033.93" upper_limit="3822.71"/>
                    <measurement group_id="O2" value="3261.69" spread="2913.70" lower_limit="2913.70" upper_limit="3651.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:8 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV</title>
        <description>The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.</description>
        <time_frame>1 month post dose 3 of IPV (Month ~3.5)</time_frame>
        <population>Participants who received the 3 scheduled doses of study vaccination, adhered to guidelines for vaccine administration, provided baseline and post-vaccination blood samples within the acceptable day range, and did not have important protocol deviations are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Concomitant RotaTeq and IPV</title>
            <description>Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
          </group>
          <group group_id="O2">
            <title>Staggered RotaTeq and IPV</title>
            <description>Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:8 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV</title>
          <description>The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.</description>
          <population>Participants who received the 3 scheduled doses of study vaccination, adhered to guidelines for vaccine administration, provided baseline and post-vaccination blood samples within the acceptable day range, and did not have important protocol deviations are included.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
                <count group_id="O2" value="187"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Poliovirus Type 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" spread="98.0" lower_limit="98.0" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" spread="98.0" lower_limit="98.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poliovirus Type 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" spread="98.0" lower_limit="98.0" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" spread="98.0" lower_limit="98.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poliovirus Type 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" spread="98.0" lower_limit="98.0" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" spread="98.0" lower_limit="98.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:64 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV</title>
        <description>The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.</description>
        <time_frame>1 month postdose 3 of IPV (Month ~3.5)</time_frame>
        <population>Participants who received the 3 scheduled doses of study vaccination, adhered to guidelines for vaccine administration, provided baseline and post-vaccination blood samples within the acceptable day range, and did not have important protocol deviations are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Concomitant RotaTeq and IPV</title>
            <description>Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
          </group>
          <group group_id="O2">
            <title>Staggered RotaTeq and IPV</title>
            <description>Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:64 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV</title>
          <description>The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.</description>
          <population>Participants who received the 3 scheduled doses of study vaccination, adhered to guidelines for vaccine administration, provided baseline and post-vaccination blood samples within the acceptable day range, and did not have important protocol deviations are included.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
                <count group_id="O2" value="187"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Poliovirus Type 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.00" spread="98.0" lower_limit="98.0" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" spread="98.0" lower_limit="98.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poliovirus Type 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" spread="98.0" lower_limit="98.0" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" spread="98.0" lower_limit="98.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poliovirus Type 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" spread="98.0" lower_limit="98.0" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" spread="98.0" lower_limit="98.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Solicited Injection-Site Adverse Events</title>
        <description>Solicited injection-site adverse events (AEs) included erythema, swelling, induration, and pain at the IPV injection-site.</description>
        <time_frame>Up to 7 days following each IPV vaccination</time_frame>
        <population>All participants who received ≥1 dose of study treatment are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Concomitant RotaTeq and IPV</title>
            <description>Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
          </group>
          <group group_id="O2">
            <title>Staggered RotaTeq and IPV</title>
            <description>Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Solicited Injection-Site Adverse Events</title>
          <description>Solicited injection-site adverse events (AEs) included erythema, swelling, induration, and pain at the IPV injection-site.</description>
          <population>All participants who received ≥1 dose of study treatment are included.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="189"/>
                <count group_id="O2" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.4"/>
                    <measurement group_id="O2" value="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Solicited Systemic Adverse Events</title>
        <description>Solicited systemic AEs included diarrhea, vomiting, and elevated temperature (axillary temperature ≥37.5º C).</description>
        <time_frame>Up to 7 days following each RotaTeq and/or IPV vaccination</time_frame>
        <population>All participants who received ≥1 dose of study treatment and have data available are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Concomitant RotaTeq and IPV</title>
            <description>Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
          </group>
          <group group_id="O2">
            <title>Staggered RotaTeq and IPV</title>
            <description>Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Solicited Systemic Adverse Events</title>
          <description>Solicited systemic AEs included diarrhea, vomiting, and elevated temperature (axillary temperature ≥37.5º C).</description>
          <population>All participants who received ≥1 dose of study treatment and have data available are included.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="189"/>
                <count group_id="O2" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Elevated temperature</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="187"/>
                    <count group_id="O2" value="196"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3"/>
                    <measurement group_id="O2" value="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhoea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="189"/>
                    <count group_id="O2" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.2"/>
                    <measurement group_id="O2" value="21.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="189"/>
                    <count group_id="O2" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6"/>
                    <measurement group_id="O2" value="19.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Serious Adverse Events (SAEs)</title>
        <description>The percentage of participants with SAEs is presented. An SAE is an AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or another important medical event.</description>
        <time_frame>Up to approximately 3.5 months</time_frame>
        <population>All participants who received ≥1 dose of study treatment are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Concomitant RotaTeq and IPV</title>
            <description>Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
          </group>
          <group group_id="O2">
            <title>Staggered RotaTeq and IPV</title>
            <description>Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serious Adverse Events (SAEs)</title>
          <description>The percentage of participants with SAEs is presented. An SAE is an AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or another important medical event.</description>
          <population>All participants who received ≥1 dose of study treatment are included.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="189"/>
                <count group_id="O2" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7"/>
                    <measurement group_id="O2" value="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to approximately 3.5 months</time_frame>
      <desc>All participants who received ≥1 study-related vaccination are included.</desc>
      <group_list>
        <group group_id="E1">
          <title>Concomitant RotaTeq and IPV</title>
          <description>Participants will receive RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
        </group>
        <group group_id="E2">
          <title>Staggered RotaTeq and IPV</title>
          <description>Participants will receive RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 25.0</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="189"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="189"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="189"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="189"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="189"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Gastrointestinal viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="189"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="189"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="189"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="189"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="189"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="189"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Motor developmental delay</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="189"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Laryngeal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="189"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 25.0</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="123" subjects_at_risk="189"/>
                <counts group_id="E2" subjects_affected="143" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="43" subjects_affected="33" subjects_at_risk="189"/>
                <counts group_id="E2" events="77" subjects_affected="50" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="189"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="23" subjects_affected="20" subjects_at_risk="189"/>
                <counts group_id="E2" events="66" subjects_affected="39" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="62" subjects_affected="45" subjects_at_risk="189"/>
                <counts group_id="E2" events="45" subjects_affected="41" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="189"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="33" subjects_affected="30" subjects_at_risk="189"/>
                <counts group_id="E2" events="48" subjects_affected="37" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="189"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="40" subjects_affected="31" subjects_at_risk="189"/>
                <counts group_id="E2" events="41" subjects_affected="36" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="189"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="26" subjects_affected="19" subjects_at_risk="189"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="18" subjects_affected="17" subjects_at_risk="189"/>
                <counts group_id="E2" events="20" subjects_affected="18" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="189"/>
                <counts group_id="E2" events="18" subjects_affected="12" subjects_at_risk="200"/>
              </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>If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Protocol Amendment 3 was issued after study completion. The purpose of the amendment was to update the Sponsor entity name and address.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Clinical Trials Disclosure</name_or_title>
      <organization>Merck Sharp &amp; Dohme LLC</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.com</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/NCT04481191
org study id: V260-074
secondary id: V260-074
secondary id: 2020-003329-49
nct id: NCT04481191
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study will evaluate the immunogenicity and safety of concomitant administration of
      RotaTeq® (V260) and inactivated poliomyelitis vaccine (IPV) in Chinese infants. Its primary
      objective is to demonstrate that the immunogenicity of IPV in the concomitant-use group is
      non-inferior to the immunogenicity of IPV in the staggered-use group. The hypothesis to be
      tested is: The seroconversion percentage at 1 month post dose 3 for poliovirus types 1, 2,
      and 3 in the concomitant-use group is non-inferior to those of the staggered-use group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
time frame: Baseline and 1 month postdose 3 of IPV (Month ~3.5)
description: The immunogenicity of IPV was measured using poliovirus serum neutralizing antibody assay of the National Institutes for Food and Drug Control (NIFDC), Beijing, China. Serum conversion was defined as antibody titer ≥1:8 post-vaccination in baseline seronegative participants or ≥4-fold increase in titer post-vaccination in baseline seropositive participants.
measure: Geometric Mean Titers (GMTs) of Neutralizing Antibody to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
time frame: 1 month postdose 3 of IPV (Month ~3.5)
description: The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.
measure: Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:8 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
time frame: 1 month post dose 3 of IPV (Month ~3.5)
description: The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.
measure: Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:64 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
time frame: 1 month postdose 3 of IPV (Month ~3.5)
description: The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.
measure: Percentage of Participants With Solicited Injection-Site Adverse Events
time frame: Up to 7 days following each IPV vaccination
description: Solicited injection-site adverse events (AEs) included erythema, swelling, induration, and pain at the IPV injection-site.
measure: Percentage of Participants With Solicited Systemic Adverse Events
time frame: Up to 7 days following each RotaTeq and/or IPV vaccination
description: Solicited systemic AEs included diarrhea, vomiting, and elevated temperature (axillary temperature ≥37.5º C).
measure: Percentage of Participants With Serious Adverse Events (SAEs)
time frame: Up to approximately 3.5 months
description: The percentage of participants with SAEs is presented. An SAE is an AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or another important medical event.
arm group label: Concomitant RotaTeq and IPV
arm group type: Experimental
description: Participants will receive RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
arm group label: Staggered RotaTeq and IPV
arm group type: Active Comparator
description: Participants will receive RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
intervention type: Biological
intervention name: RotaTeq (V260)
description: Live, pentavalent rotavirus vaccine administered as a 2 mL-dose oral solution
arm group label: Concomitant RotaTeq and IPV
arm group label: Staggered RotaTeq and IPV
other name: RotaTeq
other name: V260
intervention type: Biological
intervention name: IPV
description: 0.5 mL dose IPV (Sabin strain based), administered via IM injection
arm group label: Concomitant RotaTeq and IPV
arm group label: Staggered RotaTeq and IPV
criteria: 
gender: All
minimum age: 48 Days
maximum age: 63 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
facility: 
country: China
responsible party type: Sponsor
mesh term: Poliomyelitis
mesh term: Gastroenteritis
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Protocol Amendment 3 was issued after study completion. The purpose of the amendment was to update the Sponsor entity name and address.
point of contact: 