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Status: Ongoing First registered on: 02/12/2018

Last updated on: 11/12/2018

1. Study identification

EU PAS Register NumberEUPAS26809

Official titleADVANCE Proof-of-Concept study (POC):Testing a system for near real-time monitoring of vaccination coverage, benefits and risks in Europe with acellular pertussis vaccines as test case

Study title acronymADVANCE POC: monitoring

Study typeObservational study

Brief description of the studyThe IMI-ADVANCE project (Accelerated Development of VAccine beNefit-risk Collaboration in Europe project funded by the Innovative Medicines Initiative (IMI)) is a public-private partnership aiming to develop and test a system for rapid B/R assessment and near-real time B/R monitoring of vaccines in the post-market setting using a distributed network of European electronic health record (EU EHR) databases. A set of four proof-of-concept (POC) studies were earlier conducted to assess the feasibility of and to establish processes for generating the required data to perform the B/R assessment of vaccines in Europe. Particularly, these studies assessed the feasibility for generating data for vaccination (1) coverage, (2) benefit and (3) risk, and (4) for synthesizing the obtained evidence using B/R modeling (refs). As test-case for these POC studies, it was assessed if the initial B/R profile of pertussis vaccines was maintained after the switch from whole cell pertussis (wP) vaccines to acellular pertussis (aP) vaccines. The current POC study builds further upon the previous study and assesses the feasibility of obtaining near-real time data from EU EHR databases. The success of near-real time B/R monitoring fully relies on data being timely available, i.e. both frequent up-to-date and small time-lag between the occurrence of the event and it being recorded in the databases. The current study makes use of previously developed methodological work on near-real time and visual monitoring of vaccination coverage, benefits, risks and B/R using an interactive dashboard, where the developments were based on simulated data. The objectives of the current POC study are therefore twofold: 1. to explore the capacity of EU EHR databases to provide near-real time data and 2. to demonstrate the practical potential of the proposed B/R monitoring methodology using real-world data from various EU EHR databases.

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 nameP95

Centre locationBelgium

Details of (Primary) lead investigator

Title Dr

Last name Bollaerts

First name Kaatje

Is this study being carried out with the collaboration of a research network?

Yes

ADVANCE

Other centres where this study is being conducted

Not applicable (single centre)

Countries in which this study is being conducted

International study

Denmark

Italy

Spain

United Kingdom

3. Study timelines: initial administrative steps, progress reports and final report

PlannedActual

Date when funding contract was signed10/10/2017

Start date of data collection01/03/201823/03/2018

Start date of data analysis04/06/201803/09/2018

Date of interim report, if expected

Date of final study report30/01/2019

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 schemeIMI100

5. Contact details for enquiries

Scientific Enquiries

Title Dr

Last name Bollaerts

First name Kaatje

Address line 1Vlierbeeklaan 18

Address line 2

Address line 3

CityKessel-lo

Postcode3010

CountryBelgium

Phone number (incl. country code)32-485789657

Alternative phone number

Fax number (incl. country code)

Email address kaatje.bollaerts@p-95.com

Public Enquiries

Title Dr

Last name Bollaerts

First name Kaatje

Address line 1Vlierbeeklaan 18

Address line 2

Address line 3

CityKessel-lo

Postcode3010

CountryBelgium

Phone number (incl. country code)32-485789657

Alternative phone number

Fax number (incl. country code)

Email address kaatje.bollaerts@p-95.com

11. Scope of the study

What is the scope of the study?

System testing; testing the ADVANCE system on generating near real-time data on vaccination coverage, benefits and risks.

Primary scope : System testing; testing the ADVANCE system on generating near real-time data on vaccination coverage, benefits and risks.

12. Main objective(s)

What is the main objective of the study?

The overall objective of the ADVANCE Proof of Concept (POC) studies is to build and test a system (including testing data availability) for benefit-risk monitoring of vaccines in Europe. Specifically, the objective of POC1.2 is to establish the feasibility of continuously and rapidly updating the information on coverage, benefits and risks using electronic healthcare and surveillance databases.

Are there primary outcomes?No

Are there secondary outcomes?No

13. Study design

What is the design of the study?

near real-time monitoring

14. Follow-up of patients

Will patients be followed up?Not applicable/no follow-up

15. Data analysis plan

Please provide a brief summary of the analysis method

The test case is near real-time (weekly or bi-weekly/monthly, depending on the database) visual monitoring of vaccination coverage, benefits and risks of pertussis vaccination. The monitoring will be facilitated through the use of an interactive dashboard developed based on the POC1 data. The dashboard contains three monitoring tabs with visualizations: - Coverage: number of administered doses per week over calendar time (extrapolated to the population of interest) and vaccination coverage (%) within specific age groups by calendar time - Benefits: observed pertussis incidence in the total population by calendar time - Risks: incidence rates in event specific risk windows and in control periods (out of risk windows) at vaccination eligible ages, separately for each risk outcome by dose, estimated cumulatively over calendar time.