Deliverables
The DRIVE project incorporates 53 deliverables over a five years period. These may change and/or additional deliverables may be added over the life of the project.
Completed deliverables are submitted to the IMI in accordance with the agreed timetable. A full list of the deliverables can be found here. Completed deliverables are published below as they are submitted to the IMI:
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The Development of Robust and Innovative Vaccine Effectiveness (DRIVE) project is a public-private partnership aiming to build capacity in Europe for estimating brand-specific influenza vaccine effectiveness (IVE). […]
To complement clinical trial evidence of antiviral vaccines with real-world data, platforms for surveillance, virus circulation and vaccine safety and effectiveness are needed. […]
The Development of Robust and Innovative Effectiveness (DRIVE) project was set up in July 2017 to address the challenge of brand-specific influenza vaccine effectiveness (IVE) evaluation in the Europe through a Public-Private Partnership (PPP). […]
To enable the development of a study network of Influenza Vaccines Effectiveness (IVE) studies, DRIVE developed a transparent governance model to allow the collaboration of different stakeholders, through a public-private partnership (PPP). […]
The Data Management Plan (DMP) provides a description of the data management that has been applied in the DRIVE project […]
The Development of Robust and Innovative Vaccine Effectiveness (DRIVE) project is a public-private partnership aiming to build capacity in Europe for estimating brand-specific influenza vaccine effectiveness (IVE).[…]
One of the objectives of the DRIVE (Development of Robust and Innovative Vaccine Effectiveness) project is to interpret the results of influenza vaccine effectiveness (IVE) studies and communicate their significance to different stakeholder groups. […]
The aim of this document is to describe a standard set of analytical methods that can be applied to measure IVE in the European context of diverse vaccine products, distribution, recommendations, and administration as well as diverse influenza diagnostic and therapeutic approaches. […]
DRIVE aims to establish a sufficiently sized network to generate robust, high quality, brand-specific influenza vaccine effectiveness (IVE) estimates for influenza vaccines used in the EU. […]
THL DRIVE protocol, season 2021/22 […]
The Development of Robust and Innovative Vaccine Effectiveness (DRIVE) project is a public-private partnership aiming to build capacity in Europe for estimating brand-specific influenza vaccine effectiveness (IVE). […]
The Innovative Medicines Initiative (IMI) project Development of Robust and Innovative Vaccine Effectiveness (DRIVE) aims to create a European platform for studying brand-specific influenza vaccine effectiveness (IVE) […]
The Development of Robust and Innovative Vaccine Effectiveness (DRIVE) project is an IMI-funded public-private partnership aiming to build capacity in Europe for estimating brand-specific influenza vaccine effectiveness (IVE). This is a revised and updated overall communications plan for the DRIVE project. […]
The Development of Robust and Innovative Vaccine Effectiveness (DRIVE) project is a public-private partnership aiming to build capacity in Europe for estimating brand-specific influenza vaccine effectiveness (IVE).[…]
The Development of Robust and Innovative Vaccine Effectiveness (DRIVE) project is a public-private partnership aiming to build capacity in Europe for estimating brand-specific influenza vaccine effectiveness (IVE). […]
The Innovative Medicines Initiative (IMI) project Development of Robust and Innovative Vaccine Effectiveness (DRIVE) aims to create a European platform for studying brand-specific influenza vaccine effectiveness (IVE) and to develop a governance model for scientifically robust, independent and transparent implementation of IVE studies in a public-private partnership. […]
The present document aims at providing an overview of the management and administrative procedures and principles that will ensure an efficient execution of the DRIVE project and thus contribute to the production of high quality project results. […]
The Data Management Plan (DMP) provides a description of the data management that will be applied in the DRIVE project […]
This document presents the results of the SWOT analysis implementation as outlined in D3.2 (SWOT analysis plan). […]
The present document aims at reporting the interim evaluation conducted by the consortium in order to assess the degree of fulfilment of the project’s objectives and KPIs. […]
The Development of Robust and Innovative Vaccine Effectiveness (DRIVE) project is a public-private partnership aiming to build capacity in Europe for estimating brand-specific influenza vaccine effectiveness (IVE). […]
For optimal analysis of strain specific Vaccine Effectiveness studies, a detailed characterization of the viruses detected in both cases and controls is important. […]
Beyond applying scientific robust design and methodology, quality in research also involves activities to prevent, detect, correct or control errors and may involve the use of written procedures, standardized systems and governance to ensure that quality of the output is robust. […]
DRIVE carried out a web-based survey targeting the DRIVE study sites which performed the observational studies to address the IVE by vaccine brand/type in the 2018-2019 influenza season […]
This report provides an overview of the governance of the Influenza Vaccine Effectiveness (IVE) Study Platform to date and provides an insight into the adaptations made following feedback over the course of the first year of IVE studies. […]
This deliverable presents the background, methodology, results and conclusions from the literature review that was conducted to identify potential biases, confounding factors and effect modifiers in influenza vaccine effectiveness (IVE) studies […]
During the early phases of the DRIVE project in 2017–2018, the project has established a study governance model and performed a pilot study of influenza vaccine effectiveness (IVE). The study activities take place in a separate Work Package (WP7) consisting entirely of public partners. […]
Influenza viruses undergo constant, rapid evolution, and subsequently, seasonal influenza vaccines must be regularly reformulated. The benefits-risks profile of seasonal influenza vaccines must also be regularly monitored. Assessing vaccine effectiveness in this rapidly changing environment requires the ability to capture reliable information on the core elements of vaccination. […]
Currently, measuring the effectiveness of influenza vaccines relies on observational studies which compare the occurrence of influenza in vaccinated and unvaccinated populations or the odds of vaccination in cases and non-cases. The different types of observational studies used include cohort, case-control (notably, the test-negative design) and screening method study designs. […]
The first influenza season of the DRIVE project in 2017/18 was considered a pilot. The project’s main objective in this season was to establish and test the new platform using a limited number of sites. The results of the pilot season are described in a full report and two summaries that were published on the DRIVE website (under Results, 2017/18 season) on 17 December 2018. […]
D5.7 Report on synergies identified and collaborations developed with other initiatives - 31/12/2018
The aim of deliverable 5.7 is to report synergies explored by DRIVE with external initiatives during the first reporting period of the project (2017-2018). The deliverable also presents a strategy for extending synergy identification process to support ongoing research activities. […]
DRIVE has undertaken a number of activities to capture feedback from Layer 1 stakeholders, which include the European Medicines Agency (EMA), European Centre for Disease Prevention and Control (ECDC), World Health Organization (WHO), Strategic Advisory Group of Experts (SAGE), Public Health Regulatory Bodies, Directorate-General (DG) Sante, National Immunisation Technical Advisory Groups and National Public Health Institutes: […]
The DRIVE consortium (Development of Robust and Innovative Vaccine Effectiveness) has been established to answer the updated European regulatory requirements which include annual brand-specific influenza vaccine effectiveness (IVE) estimates. This report presents the achievements and results of the pilot study 2017/2018. […]
The IMI project DRIVE aims to create a European platform for studying brand-specific influenza vaccine effectiveness (IVE) and to develop a governance model for scientifically robust, independent and transparent implementation of IVE studies in a public-private partnership. […]
The IMI project DRIVE aims to create a European platform for studying brand-specific influenza vaccine effectiveness (IVE) and to develop a governance model for scientifically robust, independent and transparent implementation of IVE studies in a public-private partnership. […]
The DRIVE consortium has been created to generate brand-specific data on the effectiveness of seasonal influenza vaccines in order to fulfil the requirements described in EMA guideline on influenza vaccines […]
Vaccines are critical in preventing influenza and its complications. DRIVE’s objective is the development of a governance model that will facilitate the development of a sustainable study platform of sufficient size to enable vaccine type/ brand-specific vaccine effectiveness (VE) studies. There is a need for a strong focus on the robustness of the data while ensuring compliance with relevant legislation and best practice standards for VE studies. […]
In the DRIVE project, influenza vaccine effectiveness (IVE) data from several independently operating national and regional study sites will be analysed together to obtain brand-specific IVE estimates. […]
In order to better assess differences on the ethical submission process and the received feedback in participating countries, DRIVE carried out a web-based survey targeting public health institutes, conducting pilot observational studies to address the IVE by vaccine brand/type 2017-2018 influenza season. […]
One of the objectives of the DRIVE (Development of Robust and Innovative Vaccine Effectiveness) project is to interpret the results of influenza vaccine effectiveness (IVE) studies and communicate their significance to various stakeholder groups. […]
The aim of this document is to describe a standard set of analytical methods that can be applied to measure IVE in the European context of diverse vaccine manufacturing, distribution, and administration as well as diverse influenza diagnostic and therapeutic approaches. This document will serve as guidance to revise the current protocols within DRIVE. […]
The aim of the DRIVE project is to develop robust evidence on brand-specific influenza vaccine effectiveness (BSIVE) in Europe. This research agenda has been developed to identify areas where increased knowledge could support decision making for regulatory purposes and for public health programs. The agenda will be shared externally to solicit input that will be discussed with relevant stakeholders at the DRIVE Forum in Rome in September 2018. It will be updated annually to monitor research advances and possible new areas to investigate. […]
The DRIVE consortium aims to enable the collaboration of different public and private stakeholders to perform annual brand-specific influenza vaccine effectiveness (IVE) studies for various influenza vaccines on the European market. To this end, IVE studies will be conducted at various study sites across Europe. In a second step, the site-specific data will be combined to obtain overall estimates at the European level. The purpose of this document is to provide guidance for writing the Statistical Analysis Plan (SAP) of combining and presenting information on IVE from different study sites. This document will be updated following the learnings from the pilot year 2017-2018. […]
In DRIVE, data from several independently operating national or regional study sites will be analysed jointly to obtain a large geographical coverage and sufficient sample size for brand-specific VE estimates. In order to harmonize the study-specific reports, DRIVE WP4 has developed a report template that can also be used for reporting the results of the joint analyses. […]
The SWOT analysis is aimed at complementing the evaluation of the WP7 pilot studies from an operational quality and operational feasibility perspective at the site level. […]
In order to better understand the communications needs of its stakeholders, DRIVE will carry out a web-based survey directed at the “level 1” stakeholders identified in deliverable 5.1 (Stakeholder map). The results of the survey will advise DRIVE on topics including the content and frequency of its communications, and the best communication channels to reach its stakeholders. […]
In order to communicate effectively about DRIVE to all stakeholders, the consortium has established a stakeholder database, based on the high level stakeholder map proposed in the DOA. The stakeholder data will utilised and regularly updated in accordance with EU privacy laws […]
The DRIVE DMP gives guidance and provides an oversight of general data management, while each study needs to provide specific data management information including, but not limited to, data capture systems, data analysis systems […]
Key drivers of expected vaccine availability and use in a country, overall and for specific population groups include: the license status in a specific country, vaccine recommendations and programs, coverage and the vaccine procurement and distribution. […]
In all the studies carried out by the DRIVE consortium, high standards of research ethics will be upheld. Additionally, participants to any DRIVE activities are expected to ensure that any relevant national and regional laws, policies and guidelines will be adequately followed. […]
This is the second draft to lay out the DRIVE overall communications plan. It includes the major elements which were agreed upon in the project proposal phase and further elaborated in the kick-off meeting. […]
This document aims at providing a plan for an effective and inclusive production of communications materials. It includes a self-explicative process description of producing and reviewing communications materials within DRIVE Project in a timely manner. […]
This Standard Operating Procedure (SOP) presents a set of governance principles and step-by-step instructions to help consortium members and external experts carrying out the following key tasks in the project:
1. the endorsement of the scientific deliverables by an Independent Scientific Committee (ISC) […]