<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/NCT01680679</url>
  </required_header>
  <id_info>
    <org_study_id>13-0210</org_study_id>
    <secondary_id>U01IP000475</secondary_id>
    <nct_id>NCT01680679</nct_id>
  </id_info>
  <brief_title>Influenza Immunization of Children in India</brief_title>
  <official_title>Influenza Immunization of Children in India</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>All India Institute of Medical Sciences, New Delhi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Clinical Epidemiology Network (INCLEN) TRUST</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Influenza viruses are significant causes of human illness and death in developed and&#xD;
      developing countries. This study will measure the ability of influenza vaccine given to&#xD;
      children in India to protect both the children and unimmunized persons around them from&#xD;
      influenza. It will also determine whether the best time to immunize in a country like India&#xD;
      that has both summer and winter outbreaks of influenza is in the fall, as is done now, or&#xD;
      whether immunization should be in the spring to protect against influenza infections in the&#xD;
      summer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although influenza vaccines are used routinely in the United States, including in young&#xD;
      children, influenza vaccines have not seen widespread use in India. This is likely&#xD;
      contributed to by the lack of information from India about disease burden due to influenza&#xD;
      and because influenza vaccines have not been tested for efficacy in India. In addition,&#xD;
      because young children are thought to be important in the spread of influenza in families, it&#xD;
      is possible immunization of children against influenza will reduce influenza infections among&#xD;
      older children and adults in the home. The study described here is an extension of an earlier&#xD;
      study (ClinicalTrials.gov NCT00934245) that tested the use of immunization against influenza&#xD;
      in the fall. The current study will administer influenza vaccine in the spring prior to the&#xD;
      summer monsoon rains that are associated with peaks of influenza activity in parts of India.&#xD;
      Reduction of influenza infections among the influenza immunized children and their household&#xD;
      members will be compared to the children and household members in the control vaccine group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Laboratory-confirmed influenza infection in vaccinated child</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Laboratory-confirmed influenza infection in household member of a vaccinated child.</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">18163</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Inactivated Trivalent Influenza Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inactivated trivalent influenza vaccine (TIV), split virion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inactivated Polio Vaccine</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Inactivated poliovirus vaccine (IPV), trivalent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surveillance arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Those ineligible for vaccination will be enrolled for febrile acute respiratory illness (FARI) surveillance to assess indirect effects of vaccination in household members.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Inactivated Trivalent Influenza Vaccine (TIV)</intervention_name>
    <arm_group_label>Inactivated Trivalent Influenza Vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Inactivated poliovirus vaccine (IPV), trivalent</intervention_name>
    <arm_group_label>Inactivated Polio Vaccine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion in either vaccine group (TIV or IPV) will require ages 6 months through 10 years&#xD;
        of age.&#xD;
&#xD;
        All individuals in enrolled households will be eligible for enrollment into surveillance&#xD;
        arm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria from the vaccine groups includes known allergy to eggs, or&#xD;
        hypersensitivity to other components of the vaccines.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wayne Sullender, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shobha Broor, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>All India Institute of Medical Sciences, New Delhi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Comprehensive Rural Health Services Project</name>
      <address>
        <city>Ballabgarh</city>
        <state>Haryana</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>March 23, 2017</last_update_submitted>
  <last_update_submitted_qc>March 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>India</keyword>
  <keyword>Children</keyword>
  <keyword>Trivalent Influenza Vaccine (TIV)</keyword>
  <keyword>Inactivated poliovirus vaccine (IPV)</keyword>
  <keyword>Direct influenza vaccine effectiveness</keyword>
  <keyword>Total influenza vaccine effectiveness</keyword>
  <keyword>Indirect influenza vaccine effectiveness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01680679
org study id: 13-0210
secondary id: U01IP000475
nct id: NCT01680679
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Influenza viruses are significant causes of human illness and death in developed and
      developing countries. This study will measure the ability of influenza vaccine given to
      children in India to protect both the children and unimmunized persons around them from
      influenza. It will also determine whether the best time to immunize in a country like India
      that has both summer and winter outbreaks of influenza is in the fall, as is done now, or
      whether immunization should be in the spring to protect against influenza infections in the
      summer.
Although influenza vaccines are used routinely in the United States, including in young
      children, influenza vaccines have not seen widespread use in India. This is likely
      contributed to by the lack of information from India about disease burden due to influenza
      and because influenza vaccines have not been tested for efficacy in India. In addition,
      because young children are thought to be important in the spread of influenza in families, it
      is possible immunization of children against influenza will reduce influenza infections among
      older children and adults in the home. The study described here is an extension of an earlier
      study (ClinicalTrials.gov NCT00934245) that tested the use of immunization against influenza
      in the fall. The current study will administer influenza vaccine in the spring prior to the
      summer monsoon rains that are associated with peaks of influenza activity in parts of India.
      Reduction of influenza infections among the influenza immunized children and their household
      members will be compared to the children and household members in the control vaccine group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Laboratory-confirmed influenza infection in vaccinated child
time frame: 1 year
measure: Laboratory-confirmed influenza infection in household member of a vaccinated child.
time frame: 1 year
arm group label: Inactivated Trivalent Influenza Vaccine
arm group type: Experimental
description: Inactivated trivalent influenza vaccine (TIV), split virion
arm group label: Inactivated Polio Vaccine
arm group type: Placebo Comparator
description: Inactivated poliovirus vaccine (IPV), trivalent
arm group label: Surveillance arm
arm group type: No Intervention
description: Those ineligible for vaccination will be enrolled for febrile acute respiratory illness (FARI) surveillance to assess indirect effects of vaccination in household members.
intervention type: Biological
intervention name: Inactivated Trivalent Influenza Vaccine (TIV)
arm group label: Inactivated Trivalent Influenza Vaccine
intervention type: Biological
intervention name: Inactivated poliovirus vaccine (IPV), trivalent
arm group label: Inactivated Polio Vaccine
criteria: 
gender: All
minimum age: 6 Months
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wayne Sullender, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
last name: Shobha Broor, MD
role: Principal Investigator
affiliation: All India Institute of Medical Sciences, New Delhi
facility: 
country: India
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Vaccines