Study identification

PURI

https://redirect.ema.europa.eu/resource/27852

EU PAS number

EUPAS27851

Study ID

27852

Official title and acronym

Exposure and coverage to routine schedule vaccines in different EU countries (ADVANCE-POC2)

DARWIN EU® study

No

Study countries

Belgium
Denmark
Italy
Netherlands
Spain
Switzerland
United Kingdom
United States

Study description

Rationale and Background: To increase readiness of European data sources to conduct multi-site vaccine coverage, benefit and risk studiesResearch 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 benchmarksStudy Design: The main study design is a retrospective dynamic cohort studyPopulation: 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 NetherlandsInformative data sourcesVaccine schedules: European Centre for Disease Prevention and Control (ECDC) vaccine schedules in Europe and national statistics on vaccination coverageBenchmark 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.htmlPublished literature for HPV (Bruni, Lancet Global Health) and influenza (VENICE)

Study status

Planned
Research institution and networks

Institutions

P95 Epidemiology & Pharmacovigilance
Belgium
Colombia
Netherlands
South Africa
Thailand
United States
First published:
09/04/2024
Institution
Laboratory/Research/Testing facilityNon-Pharmaceutical companyENCePP partner
VACCINE.GRID
Switzerland
First published:
07/08/2013
Institution
Not-for-profitENCePP partner
Pedianet network
Italy
First published:
01/02/2024
Institution
Other
P95 Epidemiology & Pharmacovigilance
Belgium
Colombia
Netherlands
South Africa
Thailand
United States
First published:
09/04/2024
Institution
Laboratory/Research/Testing facilityNon-Pharmaceutical companyENCePP partner
Pfizer
First published:
01/02/2024
Institution
Sciensano Brussels, RIVM the Netherlands, RCGP-RSC United Kingdom, PEDIANET Italy, ATS-Valpadana Italy, Pfizer USA

Networks

Contact details

Miriam Sturkenboom

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
EU institutional research programme

More details on funding

Innovative Medicines Initiative
Study protocol
Initial protocol
English (744.23 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable