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  • Periodic Reporting for period 1 - I-MOVE-plus (I-MOVE+ Integrated Monitoring of Vaccines Effects in Europe: a platform to measure and compare effectiveness and impact of influenza and pneumococcal vaccines and vaccination strategies in the elderly)

I-MOVE-plus Report Summary

Project ID: 634446
Funded under: H2020-EU.3.1.

Periodic Reporting for period 1 - I-MOVE-plus (I-MOVE+ Integrated Monitoring of Vaccines Effects in Europe: a platform to measure and compare effectiveness and impact of influenza and pneumococcal vaccines and vaccination strategies in the elderly)

Reporting period: 2015-05-01 to 2016-04-30

Summary of the context and overall objectives of the project

The I-MOVE+ (Integrated Monitoring of Vaccines in Europe) is a consortium of 26 European Union/European Economic Area (EU/EEA) partners (regional and national public health Institutes, SME, Universities). Its goal is to develop a sustainable platform of primary care, hospital and laboratory networks in the EU that can share and use validated standardised methods to serve the post marketing evaluation of existing and new vaccines programmes independently from commercial interests.
I-MOVE+ is based on a multi-country multidisciplinary network of clinicians, epidemiologists, laboratory specialists, statisticians, modellers and economists from a network of 15 EU/EEA Member States.

During the period covered by the project, I-MOVE+ will identify, pilot test, use, and disseminate in and beyond the European Union/European Economic Area the best study designs to measure,the effectiveness and impact of vaccines used in the elderly population to prevent influenza and pneumococcal infections. I-MOVE+ will produce evidence for informing decision making in the management of influenza and pneumococcal disease in the elderly population.

Influenza: We measure at primary care and hospital level, early and late in the season, the direct effect (effectiveness) and indirect effect of various brand and types of influenza vaccines against a core set of clinical (Influenza-like illness (ILI)/Acute Respiratory Infections (ARI), hospitalisation) and laboratory confirmed (PCR positive) outcomes in order to:
• understand the factors affecting vaccine effectiveness (VE), the duration of protection, the role of repeated seasonal vaccinations,
• identify key virus phenotypic or genotypic evolutions that could affect vaccine performances,
• identify vaccine types (adjuvanted vs not adjuvanted, live vs attenuated, trivalent vs quadrivalent) and brands with different effectiveness,
• understand the potential indirect effect of influenza vaccination in children on influenza incidence in the elderly in countries that have introduced universal influenza vaccination in children into their vaccination programme (Finland, United Kingdom).

Results will also provide responses to the new European Medicine Agency (EMA) vaccine requirements, and guide the annual recommendation of the World Health Organization (WHO) committee on specific influenza vaccine strains content.

Pneumococcal pneumonia: We measure the effectiveness (direct effect) of available vaccines and the impact of pneumococcal vaccination programmes (indirect and overall effect) against laboratory confirmed (serotype specific) cases of invasive pneumococcal disease (IPD) and a core set of clinically defined outcomes (pneumonia). In this way we will provide evidence on the occurrence and magnitude of serotype replacement following introduction of conjugate vaccination.

The above influenza and pneumococcal studies will provide robust benefit indicators (effectiveness and impact) to:
• feed comparable cost effectiveness and risk benefit analyses at member states and EU level,
• provide evidence to guide national immunisation policy makers on the most appropriate vaccination strategies (vaccine selection, schedules, doses, boosters, repeated vaccination),
• provide evidence of the combined effect of influenza and pneumococcal vaccines in reducing the burden of infectious respiratory diseases in the elderly.

I-MOVE+ is structured in five Work Packages:
WP1: Scientific Coordination and Management
WP2: Influenza vaccines
WP3: Pneumococcal vaccines
WP4: Electronic databases and registries
WP5: Cost-effectiveness analysis

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

- Kick-off meeting 29-30 May 2015, Paris
. Consortium Agreement signed
- Steering-Scientific Committee constituted, 29 May 2015
- Executive Board constituted, 29th May 2015
- Website development:
- Executive Board meetings: 29 May 2015, 10 September 2015, 12 November 2015, 19 February 2016
. Presentation of I-MOVE+ in the Horizon 2020 information meeting, 7 July 2015, Paris (organised by the Chamber of industry and trade and the French Ministry of Research)
. Participation in the Horizon 2020 Coordinators- Day, 24 February 2016
. Grant agreement amendment no 1 signed on 16 February 2016
. Organisation of 4 meetings
- Three generic protocols to measure influenza vaccine effectiveness finalised:
o Screening method
o Test-negative design (TND) at primary care level
o Test-negative design at hospital level

- Generic protocol to measure the impact of influenza vaccination programmes finalised

- Study sites TND protocols submitted, ethical approvals obtained, studies ongoing in:
o 23 hospitals in 12 sites: CNIPH-Croatia, THL-Finland, Assistance Publique Hôpitaux de Paris-France, Centre Hospitalier Universitaire Montpellier-France, OCMO-Hungary, ISS-Italy, NIZP-PZH-Poland, INS Ricardo Jorge-Portugal, INCDMIC Cantacuzino-Romania, ISPL-Navarra, ISCIII-Spainm RIVM-The Netherlands

o 11 primary care sites: CNIPH-Croatia, Réseau Sentinelles-France, RKI-Germany, OCMO-Hungary, HPSC-Ireland, ISS-Italy, RIVM-The Netherlands, NIZP-PZH-Poland, INS Ricardo Jorge-Portugal, INCDMIC Cantacuzino-Romania, ISCIII-Spain.

- Study sites screening protocols submitted, four studies ongoing in: Réseau Sentinelles-France, ISPL-Navarra, INS Ricardo Jorge-Portugal, RIVM-The Netherlands
- Study sites impact protocols submitted, studies ongoing in: NHS-Scotland, ISCIII-Spain, ISPL-Navarra, INS Ricardo Jorge-Portugal, RIVM-The Netherlands
- Seasonal VE studies ongoing
- Recruitment table available on the I-MOVE+ website to follow the recruitment of cases and controls in each study site
- Study sites visits to 14 hospitals (November 2015-April 2016)
- Technical meeting held in Madrid, 14.15 January 2016
- Pooled interim Influenza vaccine effectiveness results at primary care level available (including data up to week 3/2016 and submitted to the WHO strain selection northern hemisphere vaccine composition committee (
. Pooled interim influenza vaccine effectiveness results at hospital level
. Final analysis of the 2015-16 influenza studies ongoing
. Article presenting mid-season influenza VE from the UK published in Eurosurveillance (

- Generic protocols for effectiveness and impact of studies of pneumococcal vaccines finalised
- Study sites protocols submitted and ethical approvals obtained:
Five sites will conduct vaccine effectiveness studies against IPD: SSI- -Denmark (feasibility to be evaluated), NIPH-, ISPLN-Navarra, HPS-Scotland, DH-England and Wales
One site will conduct a feasibility study for vaccine effectiveness on CAP at primary level: INS Ricardo Jorge-Portugal
Nine sites will conduct impact studies on IPD using surveillance data or hospital discharge database: SSI-Denmark, THL-Finland, HPSC-Scotland, NIPH, ISPLN-Navarra, HPS-Scotland, DH-England and Wales, INS Ricardo Jorge-Portugal, RIVM-The Netherlands

- Technical meeting held in Copenhagen, 9 September 2015
- Survey on data available for pneumococcal studies conducted
. Baseleine data for baseline of joint impact analysis up to 2014 collected

- Survey to describe influenza and pneumococcal outcomes in study sites databases and comparability of databases. Report finalised
- Study sites protocols submitted and ethical approvals obtained
o Primary care studies: Nivel- The Netherlands, ISPL-Navarra, NHS-Scotland, PHE-England
o Secondary care studies: ISPL-Navarra, NHS-Scotland, SSI-Denmark, THL-Finland
- Technical meeting held in Copenahgen 9-10 September 2015
. Publication in Eurosurveillance of an article presenting the influenza VE in adults 65 years and older in Denmark, 2015/16 (

- Survey to identify partners interested in participating in cost-effectiveness studies finalised and presented to the Executive Board
- Key project staff appointed
- Survey of partners capacity and needs in the area of influenza and pneumococcal vaccination modelling and economic evaluation completed
- Technical meeitng held in London 25-26 January 2016
. Data to fulfill deliverables D5.1 (cross-country comparison of pneumococcal disease burden) and D5.2 (generic cost-effectiveness model) colected
. Early development of influenza transmission model and cost-effectiveness analysis template, written in R programming language as an open-source R-package, in preparation for deliverables 5.3 and 5.4

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The I-MOVE+ project assembles the largest ever network of study sites in the European Union (EU) and European Economic Area (15 countries, 26 beneficiaries) allowing to strengthen evaluation research in vaccinology between EU/EEA Member States.
Multicentre cohort and case control studies are used for the evaluation of the performances of influenza and pneumococcal vaccines in the 65+ years old.

The I-MOVE+ early influenza vaccine effectiveness 2015-16 results have contributed to the decision of the WHO vaccine strain selection committee to maintain the A(H1N1)pdm09 strain in the compostion of the southern seasonal influenza vaccine. Even if virological results indicated that there were new A(H1N1)pdm09 circulating, the epidemiological results suggested that the vaccine effectiveness was similar to the previous seasons.

The WP2 laboratory component (protocol to randomly select influenza strains to be characterised) has contributed to increase the number of influenza viruses characterised. Representative results were reported to the European virological surveillance system and WHO Global Flunet.

Important and innovative questions are being investigated (Duration of protection and role of repeated sesonnal influenza vaccination; serotype specific effectiveness of various pneumococcal vaccines).

An article describing I-MOVE+ and the importance of public funding in studies evaluating vaccine performances has been published in the EU Parliament Magazine.

In preparing for deliverables D5.3 (Potential indirect effects of a childhood influenza vaccination programme on the disease burden amont elderly) and D5.4 (Cost-effectiveness of vaccinating children and/or elderly against influenza) we have developed an R-package to enable us to perform multiple cost-effectiveness analyses of influenza vaccination programmes using a standardised modelling and statistical tool. The R-package combines a dynamic transmission model and cost-effectiveness analysis template.
The fluEvidenceSynthesis R-package has already been used to support the decision to extend the seasonal influenza vaccination programme in England to healthy children and will eventually be made publically available to enable other research groups to conduct their own analyses using their own data.
We envisage that this tool will be extremely valuable to both I-MOVE+ researchers, public health officials and others, and will be a welcome product of the I-MOVE+ project.

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