<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/NCT01706224</url>
  </required_header>
  <id_info>
    <org_study_id>115539</org_study_id>
    <nct_id>NCT01706224</nct_id>
  </id_info>
  <brief_title>Sero-prevalence of Anti-pertussis Antibodies and Disease Awareness Among Spanish Healthcare Professionals</brief_title>
  <official_title>Sero-prevalence of Pertussis Antibodies and Disease Awareness Among Healthcare Professionals in Spain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      This study aims to determine the sero-prevalence of anti-pertussis antibodies among&#xD;
      healthcare professionals at hospital centres in Spain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-pertussis (anti-PT) antibody levels.</measure>
    <time_frame>Day 0 of each subject at the time of enrollment.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-PT seropositivity status.</measure>
    <time_frame>Day 0 of each subject at the time of enrollment.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-PT seronegativity status.</measure>
    <time_frame>Day 0 of each subject at the time of enrollment.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the sero-prevalence of B. pertussis antibodies among healthcare professionals aged ≥ 18 years.</measure>
    <time_frame>Day 0 of each subject at the time of enrollment.</time_frame>
    <description>By age and gender, by type of healthcare professional, by hospital department of the healthcare professional, duration of service and time spent with patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the sero-prevalence of anti-pertussis antibodies among healthcare professionals by vaccination history.</measure>
    <time_frame>Day 0 of each subject at the time of enrollment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the sero-prevalence of anti-pertussis antibodies among healthcare professionals by previous history of pertussis.</measure>
    <time_frame>Day 0 of each subject at the time of enrollment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the knowledge and beliefs about whooping cough and vaccination against pertussis among healthcare professionals.</measure>
    <time_frame>Day 0 of each subject at the time of enrollment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the household composition of healthcare professionals to identify the proportion of healthcare professionals potentially at a higher risk of contracting and transmitting pertussis.</measure>
    <time_frame>Day 0 of each subject at the time of enrollment.</time_frame>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">757</enrollment>
  <condition>Pertussis</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Subjects in this group will be all physicians actively working at hospital centres in Spain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>Subjects in this group will be all nurses actively working at hospital centres in Spain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <description>Subjects in this group will be all ancillary nursing professionals actively working at hospital centres in Spain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <description>Subjects in this group will be all midwives actively working at hospital centres in Spain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>Samples will be tested to determine the presence of anti-pertussis antibodies.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection</intervention_name>
    <description>Electronic Case Report Forms (eCRF)</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection</intervention_name>
    <description>Questionnaires, active questioning.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthcare professionals actively working and involved with patient care in Spanish&#xD;
        hospitals.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent obtained from the subject.&#xD;
&#xD;
          -  Subjects who the investigator believes that they can and will comply with the&#xD;
             requirements of the protocol.&#xD;
&#xD;
          -  Male and female healthcare professionals aged ≥18 years from selected hospitals.&#xD;
&#xD;
          -  Healthcare professionals in frequent contact with patients in the hospitals.&#xD;
&#xD;
          -  Agreeing for collection of a blood sample for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Medical students working as healthcare professionals.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hospitalet de Llobregat</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>La Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Majadahonda</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>January 9, 2014</last_update_submitted>
  <last_update_submitted_qc>January 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pertussis antibodies</keyword>
  <keyword>Bordetella pertussis</keyword>
  <keyword>sero-prevalence</keyword>
  <keyword>Healthcare professionals (HCP)</keyword>
  <keyword>Spain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Whooping Cough</mesh_term>
  </condition_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/NCT01706224
org study id: 115539
nct id: NCT01706224
lead sponsor: 
This study aims to determine the sero-prevalence of anti-pertussis antibodies among
      healthcare professionals at hospital centres in Spain.
observational model: Cohort
time perspective: Cross-Sectional
measure: Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-pertussis (anti-PT) antibody levels.
time frame: Day 0 of each subject at the time of enrollment.
measure: Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-PT seropositivity status.
time frame: Day 0 of each subject at the time of enrollment.
measure: Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-PT seronegativity status.
time frame: Day 0 of each subject at the time of enrollment.
measure: Evaluation of the sero-prevalence of B. pertussis antibodies among healthcare professionals aged ≥ 18 years.
time frame: Day 0 of each subject at the time of enrollment.
description: By age and gender, by type of healthcare professional, by hospital department of the healthcare professional, duration of service and time spent with patients.
measure: Evaluation of the sero-prevalence of anti-pertussis antibodies among healthcare professionals by vaccination history.
time frame: Day 0 of each subject at the time of enrollment.
measure: Evaluation of the sero-prevalence of anti-pertussis antibodies among healthcare professionals by previous history of pertussis.
time frame: Day 0 of each subject at the time of enrollment.
measure: Description of the knowledge and beliefs about whooping cough and vaccination against pertussis among healthcare professionals.
time frame: Day 0 of each subject at the time of enrollment.
measure: Description of the household composition of healthcare professionals to identify the proportion of healthcare professionals potentially at a higher risk of contracting and transmitting pertussis.
time frame: Day 0 of each subject at the time of enrollment.
arm group label: Group A
description: Subjects in this group will be all physicians actively working at hospital centres in Spain.
arm group label: Group B
description: Subjects in this group will be all nurses actively working at hospital centres in Spain.
arm group label: Group C
description: Subjects in this group will be all ancillary nursing professionals actively working at hospital centres in Spain.
arm group label: Group D
description: Subjects in this group will be all midwives actively working at hospital centres in Spain.
intervention type: Procedure
intervention name: Blood sample
description: Samples will be tested to determine the presence of anti-pertussis antibodies.
arm group label: Group A
arm group label: Group B
arm group label: Group C
arm group label: Group D
intervention type: Other
intervention name: Data collection
description: Electronic Case Report Forms (eCRF)
arm group label: Group A
arm group label: Group B
arm group label: Group C
arm group label: Group D
intervention type: Other
intervention name: Data collection
description: Questionnaires, active questioning.
arm group label: Group A
arm group label: Group B
arm group label: Group C
arm group label: Group D
Blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Whooping Cough