<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/NCT01694329</url>
  </required_header>
  <id_info>
    <org_study_id>GSK114180</org_study_id>
    <nct_id>NCT01694329</nct_id>
  </id_info>
  <brief_title>Impact of Introduction of PHiD-CV for Nunavik Children, Quebec, Canada</brief_title>
  <acronym>Nunavik2</acronym>
  <official_title>Impact of Introduction of PHiD-CV (Pneumococcal Nontypeable H. Influenza Protein D-conjugate Vaccine) for Nunavik Children, Quebec, Canada</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHU de Quebec-Universite Laval</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>CHU de Quebec-Universite Laval</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to document the residual burden of acute upper respiratory&#xD;
      infections (AURIs), acute lower respiratory infections (ALRIs), otitis media (OMs) and&#xD;
      auditory functional and anatomical abnormalities in children under the age of 5 years in&#xD;
      Nunavik who will be exposed to PHiD-CV in combination with PCV-7 or PCV-13. The comparison&#xD;
      groups will be the cohorts of children who received no PCV vaccine (those born in 1994-1996)&#xD;
      and those exposed to PCV-7 exclusively (those born in 2003-2007).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Around 1420 children born between 2006 and 2010 had been eligible to routine immunization&#xD;
      program with pneumococcal vaccines.&#xD;
&#xD;
      The objective of this study is to document the residual burden of acute upper respiratory&#xD;
      infections (AURIs), acute lower respiratory infections (ALRIs), otitis media (OMs) and&#xD;
      auditory functional and anatomical abnormalities in children under the age of 5 years in&#xD;
      Nunavik who will be exposed to PHiD-CV in combination with PCV-7 or PCV-13. The comparison&#xD;
      groups will be the cohorts of children who received no PCV vaccine (those born in 1994-1996)&#xD;
      and those exposed to PCV-7 exclusively (those born in 2003-2007).&#xD;
&#xD;
      The specific objectives are to measure in children under the age of 5 years in Nunavik and&#xD;
      born in the period 2009 to 2010:&#xD;
&#xD;
        1. the incidence of invasive pneumococcal disease(IPD), AURIs, ALRIs and OMs;&#xD;
&#xD;
        2. the frequency of antibiotic treatments due to these diseases;&#xD;
&#xD;
        3. the frequency of hospitalizations and transfers to the South on account of ALRIs;&#xD;
&#xD;
        4. the frequency of tympanotomies and ventilation tube insertions;&#xD;
&#xD;
        5. the prevalence of anatomical and functional lesions of the middle ear at the age of 5&#xD;
           years (the main issue).&#xD;
&#xD;
      The main research hypothesis is that the incidence of AURIs, ALRIs and OMs and the prevalence&#xD;
      of sequelae from OM decreased after the implementation of PHiD-CV in 2009, as compared with&#xD;
      previous cohorts of children who were not exposed to this new vaccine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of anatomical and functional lesions of the middle ear at the age of 5 years.</measure>
    <time_frame>at age of 5 years old</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of IPDs</measure>
    <time_frame>at age of 5 years old</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of antibiotic treatments due to diseases of interest</measure>
    <time_frame>at age of 5 years old</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of hospitalizations and transfers to the South on account of ALRIs</measure>
    <time_frame>at age of 5 years old</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of tympanotomies and ventilation tube insertions</measure>
    <time_frame>at age of 5 years old</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of AURIs</measure>
    <time_frame>at age of 5 years old</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of ALRIs</measure>
    <time_frame>at age of 5 years old</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of OMs</measure>
    <time_frame>at age of 5 years old</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1420</enrollment>
  <condition>Acute Upper Respiratory Infection</condition>
  <condition>Acute Lower Respiratory Tract Infection</condition>
  <condition>Otitis Media (OM)</condition>
  <condition>Invasive Pneumococcal Disease, Protection Against</condition>
  <arm_group>
    <arm_group_label>2006-2010 cohort</arm_group_label>
    <description>cohort of children born between 2006 and 2010, and living in Nunavik</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Children of Nunavik born between 2006 and 2010, who have been exposed to PHiD-CV in&#xD;
        combination with PCV-7 or PCV-13&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Born between 2006 and 2010&#xD;
&#xD;
          -  Resident in Nunavik (province of Quebec, Canada)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Not applicable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe De Wals, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre de recherche du CHUQ</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre de recherche du CHUQ</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1R 3L5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>June 8, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>March 1, 2017</last_update_submitted>
  <last_update_submitted_qc>March 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Streptococcus pneumoniae</keyword>
  <keyword>Pneumococcal Conjugate Vaccines</keyword>
  <keyword>Immunization</keyword>
  <keyword>Otitis media</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Pneumococcal Infections</mesh_term>
    <mesh_term>Otitis</mesh_term>
    <mesh_term>Otitis Media</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>September 23, 2019</submitted>
    <returned>October 11, 2019</returned>
  </pending_results>
  <!-- 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/NCT01694329
org study id: GSK114180
nct id: NCT01694329
lead sponsor: 
collaborator: 
has dmc: No
The objective of this study is to document the residual burden of acute upper respiratory
      infections (AURIs), acute lower respiratory infections (ALRIs), otitis media (OMs) and
      auditory functional and anatomical abnormalities in children under the age of 5 years in
      Nunavik who will be exposed to PHiD-CV in combination with PCV-7 or PCV-13. The comparison
      groups will be the cohorts of children who received no PCV vaccine (those born in 1994-1996)
      and those exposed to PCV-7 exclusively (those born in 2003-2007).
Around 1420 children born between 2006 and 2010 had been eligible to routine immunization
      program with pneumococcal vaccines.

      The objective of this study is to document the residual burden of acute upper respiratory
      infections (AURIs), acute lower respiratory infections (ALRIs), otitis media (OMs) and
      auditory functional and anatomical abnormalities in children under the age of 5 years in
      Nunavik who will be exposed to PHiD-CV in combination with PCV-7 or PCV-13. The comparison
      groups will be the cohorts of children who received no PCV vaccine (those born in 1994-1996)
      and those exposed to PCV-7 exclusively (those born in 2003-2007).

      The specific objectives are to measure in children under the age of 5 years in Nunavik and
      born in the period 2009 to 2010:

        1. the incidence of invasive pneumococcal disease(IPD), AURIs, ALRIs and OMs;

        2. the frequency of antibiotic treatments due to these diseases;

        3. the frequency of hospitalizations and transfers to the South on account of ALRIs;

        4. the frequency of tympanotomies and ventilation tube insertions;

        5. the prevalence of anatomical and functional lesions of the middle ear at the age of 5
           years (the main issue).

      The main research hypothesis is that the incidence of AURIs, ALRIs and OMs and the prevalence
      of sequelae from OM decreased after the implementation of PHiD-CV in 2009, as compared with
      previous cohorts of children who were not exposed to this new vaccine.
observational model: Cohort
time perspective: Retrospective
measure: Prevalence of anatomical and functional lesions of the middle ear at the age of 5 years.
time frame: at age of 5 years old
measure: Incidence of IPDs
time frame: at age of 5 years old
measure: Frequency of antibiotic treatments due to diseases of interest
time frame: at age of 5 years old
measure: Frequency of hospitalizations and transfers to the South on account of ALRIs
time frame: at age of 5 years old
measure: Frequency of tympanotomies and ventilation tube insertions
time frame: at age of 5 years old
measure: Incidence of AURIs
time frame: at age of 5 years old
measure: Incidence of ALRIs
time frame: at age of 5 years old
measure: Incidence of OMs
time frame: at age of 5 years old
arm group label: 2006-2010 cohort
description: cohort of children born between 2006 and 2010, and living in Nunavik
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Philippe De Wals, MD PhD
role: Principal Investigator
affiliation: Centre de recherche du CHUQ
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Respiratory Tract Infections
mesh term: Pneumococcal Infections
mesh term: Otitis
mesh term: Otitis Media
submitted: September 23, 2019
returned: October 11, 2019