<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/NCT01693380</url>
  </required_header>
  <id_info>
    <org_study_id>BUTANTAN</org_study_id>
    <nct_id>NCT01693380</nct_id>
  </id_info>
  <brief_title>Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza</brief_title>
  <acronym>Xo_Gripe</acronym>
  <official_title>Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza the in São Paulo, 2009</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Butantan Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Butantan Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated&#xD;
      household members.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children and adolescents play an important role in sustaining the transmission of influenza.&#xD;
      Moreover, with the occurrence of influenza in children, there are important socioeconomic&#xD;
      consequences to families affected by the disease, related to absenteeism, expenditure on&#xD;
      health services and medication use. This study presents an evaluation of direct and indirect&#xD;
      effectiveness of influenza vaccination in school age children and their unvaccinated&#xD;
      household contacts. It was conducted in 2009, in Sao Paulo - Brazil, through a randomized&#xD;
      double-blind community trial, with six months of follow up. For the evaluation of vaccine&#xD;
      effectiveness, the influenza vaccine was used for the experimental group, and meningitis&#xD;
      conjugate and varicella vaccines for the control group. After vaccination, the volunteers and&#xD;
      their families were followed for six months, in order to identify cases of acute respiratory&#xD;
      infection (ARI) and to collect biological samples for testing with RT-PCR for diagnosis of&#xD;
      influenza.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2009</start_date>
  <completion_date type="Actual">November 2009</completion_date>
  <primary_completion_date type="Actual">June 2009</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Laboratory confirmed influenza</measure>
    <time_frame>June 01, 2009 to November 30, 2009</time_frame>
    <description>RT-PCR confirmed influenza in respiratory secretions samples</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute Repiratory Infection (ARI)</measure>
    <time_frame>6 months</time_frame>
    <description>Presence of at least of two symptoms of ARI: fever, cough, sore throat, headache, appetite loss, running nose</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of participantes with any adverse event as a measure of safety and tolerability</measure>
    <time_frame>30 days after vaccination</time_frame>
    <description>Any solicited or unsolicited adverse event</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1742</enrollment>
  <condition>Influenza</condition>
  <condition>Acute Respiratory Infection</condition>
  <arm_group>
    <arm_group_label>Influenza vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Schoolchildren from 6 to 8 years received two intra-muscular doses of 0.5 ml of inactivated influenza vaccine, of the Southern Hemisphere, 2009.&#xD;
Schoolchildren above 8 years received one intra-muscular dose of 0.5 ml of inactivated influenza vaccine, of the Southern Hemisphere, 2009.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control vaccine</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Schoolchildren received one intra-muscular dose of 0.5 ml of Meningococcal C conjugate vaccine.&#xD;
Schoolchildren under nine years of age received also one intra-muscular dose of 0.5 ml of varicella vaccine one month after the Meningococcal C vaccine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Influenza vaccine</intervention_name>
    <description>Influenza vaccine: schoolchidren in the experimental group received IM administered:&#xD;
From 6 to 9 years of age - 2 doses (0.5ml each) of the tri-valent innactivated influenza vaccine - Southern Hemisphere formulation, 2009 - one month apart.&#xD;
9 years of age and older: one dose (0.5ml) of the tri-valent innactivated influenza vaccine - Southern Hemisphere formulation, 2009 - one month apart.</description>
    <arm_group_label>Influenza vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Control vaccine</intervention_name>
    <description>Schoolchildren from 6 to 8 years of age:&#xD;
- One dose (0.5ml), IM administered, of Meningococcal C conjugate vaccine, and one dose (0.5ml), one month later, of varicella vaccine, IM administered.</description>
    <arm_group_label>Control vaccine</arm_group_label>
    <other_name>Meningococcal C conjugate vaccine</other_name>
    <other_name>Varicella vaccine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  older than six years of age;&#xD;
&#xD;
          -  live in the study area;&#xD;
&#xD;
          -  parent consent to participate, by signing the Informed Consent Form;&#xD;
&#xD;
          -  no history of anaphilaxis or hipersensitivity to eggs or eggs proteins;&#xD;
&#xD;
          -  no history no history anaphilaxis or hipersensitivity to any substances;&#xD;
&#xD;
          -  no acute disease at the moment of vaccination&#xD;
&#xD;
          -  no use of immunesupressant drugs;&#xD;
&#xD;
          -  not have received any other vaccine in the previous six months;&#xD;
&#xD;
          -  no participation in other clinical trial in the previous six months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition above mentioned.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Expedito J Luna, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Butantan Institute</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05503900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>April 3, 2023</last_update_submitted>
  <last_update_submitted_qc>April 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>Vaccination</keyword>
  <keyword>Vaccines</keyword>
  <keyword>Schoolchildren</keyword>
  <keyword>Effectiveness</keyword>
  <keyword>Intervention studies</keyword>
  <keyword>Adolescents</keyword>
  <keyword>Laboratory Confirmed Influenza</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Respiratory Tract Infections</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/NCT01693380
org study id: BUTANTAN
nct id: NCT01693380
lead sponsor: 
has dmc: Yes
Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated
      household members.
Children and adolescents play an important role in sustaining the transmission of influenza.
      Moreover, with the occurrence of influenza in children, there are important socioeconomic
      consequences to families affected by the disease, related to absenteeism, expenditure on
      health services and medication use. This study presents an evaluation of direct and indirect
      effectiveness of influenza vaccination in school age children and their unvaccinated
      household contacts. It was conducted in 2009, in Sao Paulo - Brazil, through a randomized
      double-blind community trial, with six months of follow up. For the evaluation of vaccine
      effectiveness, the influenza vaccine was used for the experimental group, and meningitis
      conjugate and varicella vaccines for the control group. After vaccination, the volunteers and
      their families were followed for six months, in order to identify cases of acute respiratory
      infection (ARI) and to collect biological samples for testing with RT-PCR for diagnosis of
      influenza.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Laboratory confirmed influenza
time frame: June 01, 2009 to November 30, 2009
description: RT-PCR confirmed influenza in respiratory secretions samples
measure: Acute Repiratory Infection (ARI)
time frame: 6 months
description: Presence of at least of two symptoms of ARI: fever, cough, sore throat, headache, appetite loss, running nose
measure: Number of participantes with any adverse event as a measure of safety and tolerability
time frame: 30 days after vaccination
description: Any solicited or unsolicited adverse event
arm group label: Influenza vaccine
arm group type: Experimental
description: Schoolchildren from 6 to 8 years received two intra-muscular doses of 0.5 ml of inactivated influenza vaccine, of the Southern Hemisphere, 2009.
Schoolchildren above 8 years received one intra-muscular dose of 0.5 ml of inactivated influenza vaccine, of the Southern Hemisphere, 2009.
arm group label: Control vaccine
arm group type: Sham Comparator
description: Schoolchildren received one intra-muscular dose of 0.5 ml of Meningococcal C conjugate vaccine.
Schoolchildren under nine years of age received also one intra-muscular dose of 0.5 ml of varicella vaccine one month after the Meningococcal C vaccine.
intervention type: Biological
intervention name: Influenza vaccine
description: Influenza vaccine: schoolchidren in the experimental group received IM administered:
From 6 to 9 years of age - 2 doses (0.5ml each) of the tri-valent innactivated influenza vaccine - Southern Hemisphere formulation, 2009 - one month apart.
9 years of age and older: one dose (0.5ml) of the tri-valent innactivated influenza vaccine - Southern Hemisphere formulation, 2009 - one month apart.
arm group label: Influenza vaccine
intervention type: Biological
intervention name: Control vaccine
description: Schoolchildren from 6 to 8 years of age:
- One dose (0.5ml), IM administered, of Meningococcal C conjugate vaccine, and one dose (0.5ml), one month later, of varicella vaccine, IM administered.
arm group label: Control vaccine
other name: Meningococcal C conjugate vaccine
other name: Varicella vaccine
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Expedito J Luna, MD
role: Principal Investigator
affiliation: University of Sao Paulo
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Respiratory Tract Infections
mesh term: Vaccines