ADVANCE 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 (ADVANCE POC: monitoring)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26944
• EU PAS number:
  EUPAS26809
• Study ID:
  26944
• Official title and acronym:
  ADVANCE 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 (ADVANCE POC: monitoring)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Italy

  Spain

  United Kingdom
• Study description:
  The 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.
• Study status:
  Ongoing

Research institution and networks

Institutions

P95 Epidemiology & Pharmacovigilance

Belgium

Colombia

Netherlands

South Africa

Thailand

United States

Networks

Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE)

Study timelines

Date when funding contract was signed

Planned: 10/10/2017

Study start date

Planned: 01/03/2018

Actual: 23/03/2018

Data analysis start date

Planned: 04/06/2018

Actual: 03/09/2018

Date of final study report

Planned: 30/01/2019

Sources of funding

EU institutional research programme

More details on funding

IMI

Study protocol

Initial protocol

ADVANCE POC12-Protocol_v2.2_FINAL_amended 160318_signed all_FINAL

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable