<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/NCT02193061</url>
  </required_header>
  <id_info>
    <org_study_id>Rota/CeNSIA</org_study_id>
    <nct_id>NCT02193061</nct_id>
  </id_info>
  <brief_title>Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs</brief_title>
  <official_title>Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between Rota Vaccine 5 and Rota Vaccine 1 Using Seven Combined Anti-rotavirus Prevention Programs: ROTA 1,ROTA 2,ROTA 3,ROTA 4,ROTA 5,ROTA 6,ROTA 7 in Infants at 2, 4 and 6 Months of Age in Mexico City.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Pediatrics, Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centro Nacional para la Salud de la Infancia y la Adolescencia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>National Institute of Pediatrics, Mexico</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assess the immunological behavior of children from 2 months of age that receive one out of&#xD;
      seven anti-rotavirus vaccination programs: Group 1 (routine schedule with two doses of RV1 -&#xD;
      Rotarix plus sterile water) and Group 2 (routine schedule with three doses of RV5 - RotaTeq)&#xD;
      versus Group 3 (one dose of monovalent vaccine followed by two doses of pentavalent vaccine),&#xD;
      Group 4 (one dose of pentavalent vaccine followed by two doses of monovalent vaccine), Group&#xD;
      5 (two doses of pentavalent vaccine followed by a dose of monovalent vaccine), Group 6 (one&#xD;
      dose of pentavalent vaccine followed by a dose of monovalent vaccine and a dose of&#xD;
      pentavalent vaccine), and Group 7 (a dose of monovalent vaccine followed by a dose of&#xD;
      pentavalent vaccine and a dose of monovalent vaccine) in children from Mexico City.&#xD;
&#xD;
      Secondary objectives&#xD;
&#xD;
        -  To describe number and features of acute diarrheal disease (ADD) due to rotavirus&#xD;
           displayed in the seven prevention schedules.&#xD;
&#xD;
        -  To describe the adverse events temporarily associated with the seven prevention&#xD;
           schedules.&#xD;
&#xD;
      Hypotheses The seroconversion percentages and geometric mean titers (GMT) of anti-rotavirus&#xD;
      antibodies from Groups 3, 4, 5, 6 and 7 are not inferior to the seroconversion percentages&#xD;
      and the GMTs induced in subjects that received the routine vaccination schedules with two&#xD;
      doses of the monovalent vaccine and three doses of the pentavalent vaccine (Groups 1 and 2).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this protocol we included 1498 at 6 to 8 weeks of age with a second visit at 2 months, a&#xD;
      third visit at 4months four visit at 5 months after the first vaccination, ( 1st, second and&#xD;
      3erd visits for vaccine administration) phone calls every month and not schedule visits at&#xD;
      the center when parents required and the last protocol visit was at one year of age This&#xD;
      follow up to one year was to access security.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2013</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>General Symptoms - Temperature</measure>
    <time_frame>subsequent 5 days since the vaccination day</time_frame>
    <description>The subject temperature will be registered with a rectal thermometer during 5 days since the vaccination day in a diary card .&#xD;
If the subject presents fever, the temperature will be recorded in a specific diary card section.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evacuation</measure>
    <time_frame>subsequent 30 days since the vaccination day</time_frame>
    <description>The number of evacuations per day and their characteristics will be registered in a diary card</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">1498</enrollment>
  <condition>Rotavirus Vaccine</condition>
  <arm_group>
    <arm_group_label>ROTA 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>two doses of monovalent vaccine Rotarix followed by one dose of sterile water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ROTA 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>three doses of pentavalent vaccine RotaTeq</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ROTA 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>one dose of monovalent Rotarix vaccine followed by two doses of pentavalent vaccine Rotateq</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ROTA 4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>one dose of pentavalent RotaTeq vaccine followed by two doses of monovalent vaccine Rotarix</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ROTA 5</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>two doses of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ROTA 6</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>one dose of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix and a dose of pentavalent vaccine RotaTeq</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ROTA 7</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>a dose of monovalent vaccine Rotarix followed by a dose of pentavalent vaccine and a dose of monovalent vaccine Rotarix</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Rotarix</intervention_name>
    <arm_group_label>ROTA 1</arm_group_label>
    <arm_group_label>ROTA 3</arm_group_label>
    <arm_group_label>ROTA 4</arm_group_label>
    <arm_group_label>ROTA 5</arm_group_label>
    <arm_group_label>ROTA 6</arm_group_label>
    <arm_group_label>ROTA 7</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>RotaTeq</intervention_name>
    <arm_group_label>ROTA 2</arm_group_label>
    <arm_group_label>ROTA 3</arm_group_label>
    <arm_group_label>ROTA 4</arm_group_label>
    <arm_group_label>ROTA 5</arm_group_label>
    <arm_group_label>ROTA 6</arm_group_label>
    <arm_group_label>ROTA 7</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject is a boy or a girl 2 months ± one week old at the time of the first dose&#xD;
             of the vaccine.&#xD;
&#xD;
          -  The subject is considered to be healthy based on the clinical history and the physical&#xD;
             examination.&#xD;
&#xD;
          -  The subject has not received any anti-rotavirus vaccine.&#xD;
&#xD;
          -  The parent/tutor fully understands the study's procedures and voluntarily accepts to&#xD;
             participate and signs a written informed consent.&#xD;
&#xD;
          -  The parent/tutor can meet the study's requirements, such as attending the programmed&#xD;
             visits and filling in the journal.&#xD;
&#xD;
          -  Written informed consent signed by the parent/tutor before any procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject has a background of serious allergic reaction to any of the vaccine's&#xD;
             components.&#xD;
&#xD;
          -  The subject has a digestive tract malformation or acute/chronic disease.&#xD;
&#xD;
          -  The subject has some kind of immunodeficiency including HIV.&#xD;
&#xD;
          -  The subject suffers from a haemato-oncological disease.&#xD;
&#xD;
          -  The subject has been under treatment with an immunosuppressing medicine including&#xD;
             prednisone for two or more weeks.&#xD;
&#xD;
          -  The subject has received gamma-globulin or any other blood-derived product or its&#xD;
             administration is programmed during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Weeks</minimum_age>
    <maximum_age>10 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Instiute of Pediatrics</name>
      <address>
        <city>México City</city>
        <state>D.f.</state>
        <zip>04530</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>August 6, 2018</last_update_submitted>
  <last_update_submitted_qc>August 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Institute of Pediatrics, Mexico</investigator_affiliation>
    <investigator_full_name>Mercedes Macias Parra</investigator_full_name>
    <investigator_title>MSc</investigator_title>
  </responsible_party>
  <keyword>Rotavirus</keyword>
  <keyword>immunological behavior</keyword>
  <keyword>Rotarix</keyword>
  <keyword>RotaTeq</keyword>
  <keyword>vaccine interchangeability</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02193061
org study id: Rota/CeNSIA
nct id: NCT02193061
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Assess the immunological behavior of children from 2 months of age that receive one out of
      seven anti-rotavirus vaccination programs: Group 1 (routine schedule with two doses of RV1 -
      Rotarix plus sterile water) and Group 2 (routine schedule with three doses of RV5 - RotaTeq)
      versus Group 3 (one dose of monovalent vaccine followed by two doses of pentavalent vaccine),
      Group 4 (one dose of pentavalent vaccine followed by two doses of monovalent vaccine), Group
      5 (two doses of pentavalent vaccine followed by a dose of monovalent vaccine), Group 6 (one
      dose of pentavalent vaccine followed by a dose of monovalent vaccine and a dose of
      pentavalent vaccine), and Group 7 (a dose of monovalent vaccine followed by a dose of
      pentavalent vaccine and a dose of monovalent vaccine) in children from Mexico City.

      Secondary objectives

        -  To describe number and features of acute diarrheal disease (ADD) due to rotavirus
           displayed in the seven prevention schedules.

        -  To describe the adverse events temporarily associated with the seven prevention
           schedules.

      Hypotheses The seroconversion percentages and geometric mean titers (GMT) of anti-rotavirus
      antibodies from Groups 3, 4, 5, 6 and 7 are not inferior to the seroconversion percentages
      and the GMTs induced in subjects that received the routine vaccination schedules with two
      doses of the monovalent vaccine and three doses of the pentavalent vaccine (Groups 1 and 2).
In this protocol we included 1498 at 6 to 8 weeks of age with a second visit at 2 months, a
      third visit at 4months four visit at 5 months after the first vaccination, ( 1st, second and
      3erd visits for vaccine administration) phone calls every month and not schedule visits at
      the center when parents required and the last protocol visit was at one year of age This
      follow up to one year was to access security.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: General Symptoms - Temperature
time frame: subsequent 5 days since the vaccination day
description: The subject temperature will be registered with a rectal thermometer during 5 days since the vaccination day in a diary card .
If the subject presents fever, the temperature will be recorded in a specific diary card section.
measure: Evacuation
time frame: subsequent 30 days since the vaccination day
description: The number of evacuations per day and their characteristics will be registered in a diary card
arm group label: ROTA 1
arm group type: Active Comparator
description: two doses of monovalent vaccine Rotarix followed by one dose of sterile water
arm group label: ROTA 2
arm group type: Active Comparator
description: three doses of pentavalent vaccine RotaTeq
arm group label: ROTA 3
arm group type: Active Comparator
description: one dose of monovalent Rotarix vaccine followed by two doses of pentavalent vaccine Rotateq
arm group label: ROTA 4
arm group type: Active Comparator
description: one dose of pentavalent RotaTeq vaccine followed by two doses of monovalent vaccine Rotarix
arm group label: ROTA 5
arm group type: Active Comparator
description: two doses of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix
arm group label: ROTA 6
arm group type: Active Comparator
description: one dose of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix and a dose of pentavalent vaccine RotaTeq
arm group label: ROTA 7
arm group type: Active Comparator
description: a dose of monovalent vaccine Rotarix followed by a dose of pentavalent vaccine and a dose of monovalent vaccine Rotarix
intervention type: Biological
intervention name: Rotarix
arm group label: ROTA 1
arm group label: ROTA 3
arm group label: ROTA 4
arm group label: ROTA 5
arm group label: ROTA 6
arm group label: ROTA 7
intervention type: Biological
intervention name: RotaTeq
arm group label: ROTA 2
arm group label: ROTA 3
arm group label: ROTA 4
arm group label: ROTA 5
arm group label: ROTA 6
arm group label: ROTA 7
criteria: 
gender: All
minimum age: 6 Weeks
maximum age: 10 Weeks
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: National Institute of Pediatrics, Mexico
investigator full name: Mercedes Macias Parra
investigator title: MSc