<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/NCT03820752</url>
  </required_header>
  <id_info>
    <org_study_id>UZVACC</org_study_id>
    <nct_id>NCT03820752</nct_id>
  </id_info>
  <brief_title>Vaccination Coverage and Level of Protection in Patients at Risk</brief_title>
  <official_title>Study of the Vaccination Coverage and Level of Protection Against Vaccine-preventable Infectious Diseases in Pediatric and Adult Risk Patients in a University Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine&#xD;
&#xD;
        1. vaccination coverage of recommended vaccines (routine childhood vaccines and vaccines&#xD;
           against seasonal flu and pneumococci) in children with chronic diseases (allergy, cystic&#xD;
           fibrosis, diabetes mellitus type 1, congenital heart disease, immunocompromised and&#xD;
           solid organ transplant patients)&#xD;
&#xD;
        2. the level of protection against measles, mumps, rubella and pertussis in children with&#xD;
           chronic diseases.&#xD;
&#xD;
        3. vaccination coverage of recommended vaccines (diphtheria, tetanus, pertussis and&#xD;
           vaccines against seasonal flu and pneumococci) in adults with chronic diseases&#xD;
           (nephropathy, diabetes mellitus, COPD, heart failure, HIV and solid organ transplant&#xD;
           patients)&#xD;
&#xD;
        4. the level of protection against diphtheria, tetanus and pertussis in adults with chronic&#xD;
           diseases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Chronically ill children&#xD;
&#xD;
           1.1 What is the vaccination status for vaccines recommended by the Superior Health&#xD;
           Council in pediatric chronically ill patients (2-16 years of age) who consult within the&#xD;
           University hospital of Leuven?&#xD;
&#xD;
           Patients with one of the following chronic conditions will be included:&#xD;
&#xD;
             -  Cystic fibrosis&#xD;
&#xD;
             -  Diabetes Mellitus type 1&#xD;
&#xD;
             -  Allergic constitution&#xD;
&#xD;
             -  Congenital heart disease&#xD;
&#xD;
             -  Solid-organ transplantpatients&#xD;
&#xD;
             -  Immunodeficiency (congenital or acquired)&#xD;
&#xD;
             -  Cancer&#xD;
&#xD;
           The vaccination coverage for the following vaccines will be determined:&#xD;
&#xD;
             -  Poliomyelitis&#xD;
&#xD;
             -  Diphtheria&#xD;
&#xD;
             -  Tetanus&#xD;
&#xD;
             -  Pertussis&#xD;
&#xD;
             -  Haemophilus influenzae type b&#xD;
&#xD;
             -  Hepatitis B&#xD;
&#xD;
             -  Measles-Mumps-Rubella&#xD;
&#xD;
             -  Pneumococci&#xD;
&#xD;
             -  Meningococcal serogroup C&#xD;
&#xD;
             -  Rotavirus&#xD;
&#xD;
             -  Diphtheria-Tetanus-Polio: booster (older than 7 years)&#xD;
&#xD;
             -  Human papillomavirus (girls of 13 yrs)&#xD;
&#xD;
             -  Seasonal flu (cystic fibrosis, immunodeficiencies)&#xD;
&#xD;
           Timeliness of the vaccines given will also be determined.&#xD;
&#xD;
           1.2 Is the vaccination coverage of pediatric patients (2-16 years of age) comparable to&#xD;
           the data on healthy children in 2012?&#xD;
&#xD;
           1.3 What are possible factors that influence coverage in this specific patient&#xD;
           populations?&#xD;
&#xD;
           1.4 If the vaccination coverage is too low (below 90-95 percent), what are possbile&#xD;
           solutions to increase the coverage rates within this group?&#xD;
&#xD;
           1.5. Determine antibody titers in this same population for the following&#xD;
           vaccine-preventable infectious diseases:&#xD;
&#xD;
             -  Measles&#xD;
&#xD;
             -  Mumps&#xD;
&#xD;
             -  Rubella&#xD;
&#xD;
             -  Pertussis&#xD;
&#xD;
           1.6 Are antibody titers in this population similar to antibody titers measured in&#xD;
           seroprevalence studies of healthy children in the same age group?&#xD;
&#xD;
        2. Adult patients at risk&#xD;
&#xD;
      2.1 What is the vaccinatiestatus for vaccines recommended by the Superior Health Council of&#xD;
      adult patients at risk (over 18 years of age) who consult within the University hospital of&#xD;
      Leuven?&#xD;
&#xD;
      Patients with one or more of the following chronic conditions will be included in the study:&#xD;
&#xD;
        -  Chronic obstructive pulmonary disease (COPD)&#xD;
&#xD;
        -  Heart failure&#xD;
&#xD;
        -  Diabetes mellitus (Type 1 and 2)&#xD;
&#xD;
        -  Chronic kidney disease (stadium IV and V)&#xD;
&#xD;
        -  Solid organ Transplant patients&#xD;
&#xD;
        -  HIV&#xD;
&#xD;
        -  HSCT&#xD;
&#xD;
      The vaccination coverage for the following vaccines will be determined:&#xD;
&#xD;
        -  Seasonal flu (yearly)&#xD;
&#xD;
        -  Diphtheria-tetanus (date of last dose)&#xD;
&#xD;
        -  Pneumococcus (1 dose/last dose before 5 years of age)&#xD;
&#xD;
        -  Pertussis (1 dose)&#xD;
&#xD;
        -  Hepatitis B (3 doses in specific risk groups)&#xD;
&#xD;
      2.2 Who immunizes these adult patients at risk?&#xD;
&#xD;
      2.3 What are possible risk factors who influences vaccination status in the adult population?&#xD;
&#xD;
      2.4 If the vaccination coverage is too low (below 90-95 percent), what are possible solutions&#xD;
      to improve this coverage in these groups?&#xD;
&#xD;
      2.5 What are the antibody titers measured in the adult risk groups with a chronic condition&#xD;
      for the following vaccine-preventable infectious diseases:&#xD;
&#xD;
        -  Diphtheria&#xD;
&#xD;
        -  Tetanus&#xD;
&#xD;
        -  Pertussis&#xD;
&#xD;
      2.6 Are antibody titers measured in this population comparable to those of healthy subjects&#xD;
      as measured in previous seroprevalence studies?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">August 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 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>Proportion of pediatric chronically ill patients correctly vaccinated with the hexavalent (DTaP-IPV-Hib-HBV), pneumococcal, rotavirus, MMR and MenC vaccine according to the Belgian recommended vaccination schedule.</measure>
    <time_frame>5 years</time_frame>
    <description>number of patients vaccinated compared to the entire group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of adult chronically ill patients correctly vaccinated diphtheria, tetanus, pneumococci, hepatitis B and influenza according to Belgian recommended vaccination schedule</measure>
    <time_frame>5 years</time_frame>
    <description>number of patients vaccinated compared to the entire group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of pediatric patients with antibodies against measles, mumps, rubella, diphtheria, tetanus and pertussis in children included in the study and who provided a blood sample</measure>
    <time_frame>5 years</time_frame>
    <description>Determination of antibodies against measles, mumps, rubella and pertussis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of adult patients with antibodies against diphtheria, tetanus and pertussis.</measure>
    <time_frame>5 years</time_frame>
    <description>Determination of antibodies against diphtheria, tetanus and pertussis</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2179</enrollment>
  <condition>Diabetes</condition>
  <condition>Chronic Kidney Disease</condition>
  <condition>Allergy</condition>
  <condition>Cystic Fibrosis</condition>
  <condition>Heart Disease</condition>
  <arm_group>
    <arm_group_label>Pediatric chronically ill patients</arm_group_label>
    <description>Through a questionnaire parents of chronically ill patients will be asked about the vaccination status of all recommended vaccines of their child. Also questions on disease, therapy and sociodemographic factors that can influence vaccination coverage will be asked.&#xD;
A blood sample to determine antibodies against measles, mumps, rubella and pertussis will be drawn from children who consent to sampling.&#xD;
The following groups of patients will be questioned: diabetes, allergy, congenital heart disease, cystic fibrosis, immunodeficiency and transplant patients, cancer patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adult chronically ill patients</arm_group_label>
    <description>Through a questionnaire chronically ill patients will be asked about their vaccination status of diphtheria, tetanus,pertussis, flu, pneumococcal and hepatitis B vaccine(s). Also questions on disease, therapy and sociodemographic factors that can influence vaccination coverage will be asked.&#xD;
A blood sample to determine antibodies against diphtheria, tetanus and pertussis will be drawn.&#xD;
The following groups of patients will be questioned: diabetes, chronic kidney disease, heart failure, COPD, immunodeficiency and transplant patients, HSCT patients.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Chronically ill patients (pediatric and adult) in follow-up at the University Hospital&#xD;
        Leuven, Belgium&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pediatric patients: be at least 2 years of age and maximum 16 ye&#xD;
&#xD;
          -  adults patients: at least 18 years of age&#xD;
&#xD;
          -  have a chronic condition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Corinne Vandermeulen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <results_reference>
    <citation>Vandermeulen C, Roelants M, Theeten H, Depoorter AM, Van Damme P, Hoppenbrouwers K. Vaccination coverage in 14-year-old adolescents: documentation, timeliness, and sociodemographic determinants. Pediatrics. 2008 Mar;121(3):e428-34. doi: 10.1542/peds.2007-1415.</citation>
    <PMID>18310163</PMID>
  </results_reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 1, 2014</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>October 22, 2020</last_update_submitted>
  <last_update_submitted_qc>October 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Prof. dr. Corinne Vandermeulen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Heart Diseases</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/NCT03820752
org study id: UZVACC
nct id: NCT03820752
lead sponsor: 
has dmc: No
The purpose of this study is to determine

        1. vaccination coverage of recommended vaccines (routine childhood vaccines and vaccines
           against seasonal flu and pneumococci) in children with chronic diseases (allergy, cystic
           fibrosis, diabetes mellitus type 1, congenital heart disease, immunocompromised and
           solid organ transplant patients)

        2. the level of protection against measles, mumps, rubella and pertussis in children with
           chronic diseases.

        3. vaccination coverage of recommended vaccines (diphtheria, tetanus, pertussis and
           vaccines against seasonal flu and pneumococci) in adults with chronic diseases
           (nephropathy, diabetes mellitus, COPD, heart failure, HIV and solid organ transplant
           patients)

        4. the level of protection against diphtheria, tetanus and pertussis in adults with chronic
           diseases.
1. Chronically ill children

           1.1 What is the vaccination status for vaccines recommended by the Superior Health
           Council in pediatric chronically ill patients (2-16 years of age) who consult within the
           University hospital of Leuven?

           Patients with one of the following chronic conditions will be included:

             -  Cystic fibrosis

             -  Diabetes Mellitus type 1

             -  Allergic constitution

             -  Congenital heart disease

             -  Solid-organ transplantpatients

             -  Immunodeficiency (congenital or acquired)

             -  Cancer

           The vaccination coverage for the following vaccines will be determined:

             -  Poliomyelitis

             -  Diphtheria

             -  Tetanus

             -  Pertussis

             -  Haemophilus influenzae type b

             -  Hepatitis B

             -  Measles-Mumps-Rubella

             -  Pneumococci

             -  Meningococcal serogroup C

             -  Rotavirus

             -  Diphtheria-Tetanus-Polio: booster (older than 7 years)

             -  Human papillomavirus (girls of 13 yrs)

             -  Seasonal flu (cystic fibrosis, immunodeficiencies)

           Timeliness of the vaccines given will also be determined.

           1.2 Is the vaccination coverage of pediatric patients (2-16 years of age) comparable to
           the data on healthy children in 2012?

           1.3 What are possible factors that influence coverage in this specific patient
           populations?

           1.4 If the vaccination coverage is too low (below 90-95 percent), what are possbile
           solutions to increase the coverage rates within this group?

           1.5. Determine antibody titers in this same population for the following
           vaccine-preventable infectious diseases:

             -  Measles

             -  Mumps

             -  Rubella

             -  Pertussis

           1.6 Are antibody titers in this population similar to antibody titers measured in
           seroprevalence studies of healthy children in the same age group?

        2. Adult patients at risk

      2.1 What is the vaccinatiestatus for vaccines recommended by the Superior Health Council of
      adult patients at risk (over 18 years of age) who consult within the University hospital of
      Leuven?

      Patients with one or more of the following chronic conditions will be included in the study:

        -  Chronic obstructive pulmonary disease (COPD)

        -  Heart failure

        -  Diabetes mellitus (Type 1 and 2)

        -  Chronic kidney disease (stadium IV and V)

        -  Solid organ Transplant patients

        -  HIV

        -  HSCT

      The vaccination coverage for the following vaccines will be determined:

        -  Seasonal flu (yearly)

        -  Diphtheria-tetanus (date of last dose)

        -  Pneumococcus (1 dose/last dose before 5 years of age)

        -  Pertussis (1 dose)

        -  Hepatitis B (3 doses in specific risk groups)

      2.2 Who immunizes these adult patients at risk?

      2.3 What are possible risk factors who influences vaccination status in the adult population?

      2.4 If the vaccination coverage is too low (below 90-95 percent), what are possible solutions
      to improve this coverage in these groups?

      2.5 What are the antibody titers measured in the adult risk groups with a chronic condition
      for the following vaccine-preventable infectious diseases:

        -  Diphtheria

        -  Tetanus

        -  Pertussis

      2.6 Are antibody titers measured in this population comparable to those of healthy subjects
      as measured in previous seroprevalence studies?
observational model: Cohort
time perspective: Retrospective
measure: Proportion of pediatric chronically ill patients correctly vaccinated with the hexavalent (DTaP-IPV-Hib-HBV), pneumococcal, rotavirus, MMR and MenC vaccine according to the Belgian recommended vaccination schedule.
time frame: 5 years
description: number of patients vaccinated compared to the entire group
measure: Proportion of adult chronically ill patients correctly vaccinated diphtheria, tetanus, pneumococci, hepatitis B and influenza according to Belgian recommended vaccination schedule
time frame: 5 years
description: number of patients vaccinated compared to the entire group
measure: Proportion of pediatric patients with antibodies against measles, mumps, rubella, diphtheria, tetanus and pertussis in children included in the study and who provided a blood sample
time frame: 5 years
description: Determination of antibodies against measles, mumps, rubella and pertussis
measure: Proportion of adult patients with antibodies against diphtheria, tetanus and pertussis.
time frame: 5 years
description: Determination of antibodies against diphtheria, tetanus and pertussis
arm group label: Pediatric chronically ill patients
description: Through a questionnaire parents of chronically ill patients will be asked about the vaccination status of all recommended vaccines of their child. Also questions on disease, therapy and sociodemographic factors that can influence vaccination coverage will be asked.
A blood sample to determine antibodies against measles, mumps, rubella and pertussis will be drawn from children who consent to sampling.
The following groups of patients will be questioned: diabetes, allergy, congenital heart disease, cystic fibrosis, immunodeficiency and transplant patients, cancer patients.
arm group label: Adult chronically ill patients
description: Through a questionnaire chronically ill patients will be asked about their vaccination status of diphtheria, tetanus,pertussis, flu, pneumococcal and hepatitis B vaccine(s). Also questions on disease, therapy and sociodemographic factors that can influence vaccination coverage will be asked.
A blood sample to determine antibodies against diphtheria, tetanus and pertussis will be drawn.
The following groups of patients will be questioned: diabetes, chronic kidney disease, heart failure, COPD, immunodeficiency and transplant patients, HSCT patients.
Serum samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 85 Years
healthy volunteers: No
last name: Corinne Vandermeulen, MD, PhD
role: Principal Investigator
affiliation: KU Leuven
facility: 
country: Belgium
citation: Vandermeulen C, Roelants M, Theeten H, Depoorter AM, Van Damme P, Hoppenbrouwers K. Vaccination coverage in 14-year-old adolescents: documentation, timeliness, and sociodemographic determinants. Pediatrics. 2008 Mar;121(3):e428-34. doi: 10.1542/peds.2007-1415.
PMID: 18310163
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Prof. dr. Corinne Vandermeulen
investigator title: Principal Investigator
mesh term: Cystic Fibrosis
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Heart Diseases