1. Study identification
EU PAS Register NumberEUPAS27851
Official titleExposure and coverage to routine schedule vaccines in different EU countries
Study title acronymADVANCE-POC2
Study typeObservational study
Brief description of the studyRationale and Background:
To increase readiness of European data sources to conduct multi-site vaccine coverage, benefit and risk studies
Research Question and Objective:
The primary objective is to determine exposure in the population, and coverage of routine vaccinations in children and elderly
The secondary objective is to coverage estimates with external benchmarks
Study Design: The main study design is a retrospective dynamic cohort study
Population: The source population comprises of all subjects registered with one of the ADVANCE participating databases, which can link vaccination and population data and have provided their willingness to participate. The study population comprises all persons who are registered during the study period that starts January 1, 2000 and ends December 31, 2018.
Outcome Parameters: Vaccine exposure and vaccine coverage
Data Sources:
Electronic health care databases (vaccine registries, record linkage, surveillance and GP based databases) currently available in the ADVANCE consortium and eligible are located in Denmark, Spain, Italy, UK and Netherlands
Informative data sources
Vaccine schedules: European Centre for Disease Prevention and Control (ECDC) vaccine schedules in Europe and national statistics on vaccination coverage
Benchmark data:
WHO estimates for following vaccines/doses in a country: BCG, DTP1, DTP3,HepB_BD, HepB3, Hib3, IPV1, MCV1, MCV2, PCV3, Pol3, RCV1, Rota, http://apps.who.int/immunization_monitoring/globalsummary/timeseries/tswucoveragedtp3.html
Published literature for HPV (Bruni, Lancet Global Health) and influenza (VENICE)
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsP95
Department/Research group
Organisation/affiliationP95
Details of (Primary) lead investigator
Title Professor
Last name Sturkenboom
First name Miriam
Is this study being carried out with the collaboration of a research network?
Yes
ADVANCE
Other centres where this study is being conducted
Multiple centres
In total how many centres are involved in this Study?14
Sciensano, Brussels
RIVM, the Netherlands
RCGP-RSC, United Kingdom
PEDIANET, Italy
ATS-Valpadana, Italy
Pfizer, USA
Countries in which this study is being conducted
International study
Belgium
Denmark
Italy
Netherlands
Spain
Switzerland
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/10/201301/10/2013
Start date of data collection01/02/2019
Start date of data analysis02/02/2019
Date of interim report, if expected31/03/2019
Date of final study report31/03/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding schemeInnovative Medicines Initiative100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Sturkenboom
First name Miriam
Address line 1leopoldlaan III
Address line 2
Address line 3
CityLeuven
Postcode
CountryBelgium
Phone number (incl. country code)32-474534868
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Sturkenboom
First name Miriam
Address line 1leopoldlaan III
Address line 2
Address line 3
CityLeuven
Postcode
CountryBelgium
Phone number (incl. country code)32-474534868
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)J07 (VIRAL VACCINES)
7. Medical conditions to be studied
Medical condition(s)No
8. Population under study
Age
Preterm newborns
Term newborns (0-27 days)
Infants and toddlers (28 days - 23 months)
Children (2 - 11 years)
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects35000000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Data sources not registered with ENCePP
RCGP-RSC, United Kingdom
ATS-Valpadana, Italy
Praeventis, Netherlands
Sources of data
Administrative database, e.g. claims database
Routine primary care electronic patient registry
Exposure registry
11. Scope of the study
What is the scope of the study?
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
To assess exposure and coverage to routine vaccinations
Are there primary outcomes?Yes
Counts and coverage
Are there secondary outcomes?Yes
Comparisons against WHO benchmarks
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
from 2000 till 2018
15. Data analysis plan
Please provide a brief summary of the analysis method
Exposure and coverage estimation using point prevalence, point prevalence adjusted for follow-up and cumulative distribution function
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Available when the study ends
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted