Status: Planned First registered on: 02/02/2019
Last updated on: 02/02/2019
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
Website/Homepagewww.P-95.com
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

IDIAPJGol
UMCU
P95
Aarhus University Dept. of Clinical Epidemiology
ARS
VACCINE.GRID
AEMPS
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) 
Email address m.c.j.sturkenboom@umcutrecht.nl
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) 
Email address m.c.j.sturkenboom@umcutrecht.nl 
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