COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vaccination Coverage and Level of Protection in Patients at Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820752
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. dr. Corinne Vandermeulen, KU Leuven

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease
Diabetes Chronic Kidney Disease Allergy Cystic Fibrosis Heart Disease

Show Show detailed description
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 2179 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Study Start Date : October 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diphtheria Tetanus

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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. [ Time Frame: 5 years ]
    number of patients vaccinated compared to the entire group

  2. 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 ]
    number of patients vaccinated compared to the entire group


Secondary Outcome Measures :
  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 [ Time Frame: 5 years ]
    Determination of antibodies against measles, mumps, rubella and pertussis

  2. Proportion of adult patients with antibodies against diphtheria, tetanus and pertussis. [ Time Frame: 5 years ]
    Determination of antibodies against diphtheria, tetanus and pertussis


Biospecimen Retention:   Samples Without DNA
Serum samples

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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:

-

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820752


Locations
Layout table for location information
Belgium
UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Layout table for investigator information
Principal Investigator: Corinne Vandermeulen, MD, PhD KU Leuven
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Prof. dr. Corinne Vandermeulen, Principal Investigator, KU Leuven
ClinicalTrials.gov Identifier: NCT03820752    
Other Study ID Numbers: UZVACC
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Kidney Diseases
Renal Insufficiency, Chronic
Heart Diseases
Urologic Diseases
Cardiovascular Diseases
Renal Insufficiency
 Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases