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Vaccination Coverage and Level of Protection in Patients at Risk

Study of the Vaccination Coverage and Level of Protection Against Vaccine-preventable Infectious Diseases in Pediatric and Adult Risk Patients in a University Hospital

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03820752
Enrollment
2179
Registered
2019-01-29
Start date
2014-10-31
Completion date
2020-08-30
Last updated
2020-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy, Chronic Kidney Disease, Cystic Fibrosis, Diabetes, Heart Disease

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.

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?

Interventions

None listed

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 85 Years
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
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.5 yearsnumber of patients vaccinated compared to the entire group
Proportion of adult chronically ill patients correctly vaccinated diphtheria, tetanus, pneumococci, hepatitis B and influenza according to Belgian recommended vaccination schedule5 yearsnumber of patients vaccinated compared to the entire group

Secondary

MeasureTime frameDescription
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 sample5 yearsDetermination of antibodies against measles, mumps, rubella and pertussis
Proportion of adult patients with antibodies against diphtheria, tetanus and pertussis.5 yearsDetermination of antibodies against diphtheria, tetanus and pertussis

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026