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CompletedNCT03820752Updated Oct 23, 2020

Vaccination Coverage and Level of Protection in Patients at Risk

An observational study in Diabetes, Chronic Kidney Disease and Allergy, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 2 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-10-23.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,179
Ages
2 Years to 85 Years
Sex
All
01

Study summary

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.
Read the detailed description
  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?

02

Conditions studied

  • Diabetes
  • Chronic Kidney Disease
  • Allergy
  • Cystic Fibrosis
  • Heart Disease
03

In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 2,179 is above the median of 85 across 482 observational studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Chronically ill patients (pediatric and adult) in follow-up at the University Hospital Leuven, Belgium

Inclusion criteria

  • pediatric patients: be at least 2 years of age and maximum 16 ye
  • adults patients: at least 18 years of age
  • have a chronic condition

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,179 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Pediatric chronically ill patients

    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.

  • Adult chronically ill patients

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    number of patients vaccinated compared to the entire group

    Time frame: 5 years

  2. Proportion of adult chronically ill patients correctly vaccinated diphtheria, tetanus, pneumococci, hepatitis B and influenza according to Belgian recommended vaccination schedule

    number of patients vaccinated compared to the entire group

    Time frame: 5 years

Secondary outcomes

  1. 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

    Determination of antibodies against measles, mumps, rubella and pertussis

    Time frame: 5 years

  2. Proportion of adult patients with antibodies against diphtheria, tetanus and pertussis.

    Determination of antibodies against diphtheria, tetanus and pertussis

    Time frame: 5 years

07

Study locations

1 site
  • UZ Leuven
    Leuven, 3000, Belgium
08

References and documents

Publications

  • 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. PubMed 18310163 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03820752
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Prof. dr. Corinne Vandermeulen (Principal Investigator, KU Leuven) — Principal investigator
First posted
Jan 29, 2019
Start date
Oct 2014
Primary completion
Jun 2017
Completion
Aug 30, 2020
Last update
Oct 23, 2020

Study contacts

Corinne Vandermeulen, MD, PhD
principal investigator · KU Leuven

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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