DiabetesNCT03820752
Vaccination Coverage and Level of Protection in Patients at Risk
An observational study of Diabetes and Chronic Kidney Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 85 years
- Conditions the study is for
- Diabetes, Chronic Kidney Disease, Allergy
- Type of treatment
- Vaccines
- How many people
- 2,179 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2014to 30 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chronically ill patients (pediatric and adult) in follow-up at the University Hospital Leuven, Belgium
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to determine
- 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)
- the level of protection against measles, mumps, rubella and pertussis in children with chronic diseases.
- 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)
- the level of protection against diphtheria, tetanus and pertussis in adults with chronic diseases.
Read the detailed description
- 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?
- 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?
- Conditions
- Diabetes, Chronic Kidney Disease, Allergy, Cystic Fibrosis, Heart Disease
- Medical subject headings
- Diabetes Mellitus, Renal Insufficiency, Chronic, Hypersensitivity, Cystic Fibrosis, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
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
Measured: 5 years
Secondary outcomes (2)
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
Measured: 5 years
Proportion of adult patients with antibodies against diphtheria, tetanus and pertussis.
Determination of antibodies against diphtheria, tetanus and pertussis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study startOct 2014
- Primary completionJun 2017
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. dr. Corinne Vandermeulen, KU Leuven
- Investigators
- Corinne Vandermeulen, MD, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820752
- Sponsor's protocol ID
- UZVACC
- Status last verified
- Oct 2020
- First submitted
- 1 Dec 2014
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03820752
- Acronym / sponsor ID
- UZVACC
- Conditions
- Diabetes, Chronic Kidney Disease, Allergy, Cystic Fibrosis, Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,179 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine
- 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)
- the level of protection against measles, mumps, rubella and pertussis in children with chronic diseases.
- 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)
- the level of protection against diphtheria, tetanus and pertussis in adults with chronic diseases.
Detailed description
- 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?
- 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?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chronically ill patients (pediatric and adult) in follow-up at the University Hospital Leuven, Belgium
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
2 secondary outcomes
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
Proportion of adult patients with antibodies against diphtheria, tetanus and pertussis.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Results publication: PubMed 18310163Vandermeulen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Vandermeulen, MD, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Chronic Kidney Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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. (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03820752, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.