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Development of Robust and Innovative Vaccine Effectiveness

Deliverables

Report on the Governance SOP implementation

Report on the implementation of D1.2 co-led by IRD and SP

Methodology guidelines for concerted analysis of data and control of confounding factors

This report will be led by P95 together ABBOT. It will be submmitted in M4 and updated on M55.

First seasonal final report of conducted studies

Final report on the analysis of the seasonal results to be produced annually

Report on the brand availability and usage of specific influenza vaccine brands

This report will be co-led by ISS and SEQIRUS, submmited in M12 and periodically updated.

Report templates

This report will be led by P95 and ABBOT, submmitted in M8 periodically updated in M15, M27, M39 and M59.

Project assessment

Project assessment

Mid-Term DMP

Mid-term update of D4.2

Guideline for the identification of vaccine status and vaccine used in study participants

This deliverable will be co-led by FISABIO and GSK. It will be submmitted in M16 and will have periodic updates.

Second seasonal final report of conducted studies

Final report on the analysis of the seasonal results to be produced annually

Third seasonal final report of conducted studies

Final report on the analysis of the seasonal results to be produced annually

Report with the definition of the ethics policies handbooks collection

This deliverable will be co-led by FISABIO and SYNAPSE

Generic SAP

This deliverables will be led by P95 and ABBOT.

Project Handbook

Project Handbook

Evaluation reports of how the vaccine effectiveness results could fulfil the new regulatory requirements

The lead beneficiaries of this deliverable will be IABS-EU and SEQIRUS. It will be delivered in M15 and annually updated.

SWOT analysis plan and list of quality criteria

This deliverable will be co-led by ISS and SEQIRUS

Annual tender for influenza vaccine effectiveness study conduct

This report will be led by FISABIO and GSK, submmitted in M16 and updated on M28 and M40

Standard Operating Procedures (SOPs) and templates

Deliverables co-led by SURREY and GSK. It will be submmited in month 8 and annually updated.

Written report on quality and feasibility evaluation

This deliverables will be led by ISS and SEQIRUS. It will be submmitted in M14 and periodically updated.

Multi Stake-holder Research Agenda

This deliverable will be co-led by IRD and SP. It will be submmitted in M10 and annually updated.

Agreement on communications governance model

Deliverable co-led by THL and SEQIRUS

Periodical back-to-back Forum of key stakeholders […]

Deliverable co-led by THL and IABS-EU. It will be reviewed annually after its submmission in M14.

Development of the communications plan

Deliverable co-led by THL and SEQIRUS. It will be submmitted in M12 and will have periodic updates.

Fourth seasonal final report of conducted studies

Final report on the analysis of the seasonal results to be produced annually

Updated and developed protocol for type- and brand- specific IVES

This report will have periodic updates on M11, M23 and M35

Report on the comparison of adapted local protocols and Ethical Committee evaluation in each study site

This report will be led by UNIFI and SEQIRUS, submmited in M12 and it will have periodic updates

Report on the sources for usage of specific influenza vaccine brands and accessibility

This report will be led by P95 and SEQIRUS, submmitted in M6 and periodically updated

Report on the collected feed-back from “layer 1” […]

Report co-led by THL and SEQIRUS. It will be submmited in M14 and will have periodic updates.

Governance Standard Operating Procedures (SOP)

This report will be co-led by IRD and SP. It will be submmitted in M3

Generic DMP

This deliverables will be co-led by P95 and ABBOT. It will be submmitted in M6 and updated on M30 and M60 (separate deliverables).

Report on feasibility study for influenza virus characterization, molecular epidemiology studies related to influenza related disease in vaccinated and unvaccinated subjects

Report on feasibility study for influenza virus characterization, molecular epidemiology studies related to influenza related disease in vaccinated and unvaccinated subjects

Points to consider document on the interpretation of VE results

This report will also be co-led by P95 and ABBOT, submmitted in M12 annually updated.

Electronic study support application

Lead participants of this delivable will also be FISABIO and GSK

IT infrastructure to receive and analyse the data

This deliverables will be led by P95.

Publications

Brand-specific influenza vaccine effectiveness estimates during 2019/20 season in Europe – Results from the DRIVE EU study platform

Author(s): Anke L. Stuurman, Jorne Biccler, Antonio Carmona, Alexandre Descamps, Javier Díez-Domingo, Cintia Muñoz Quiles, Hanna Nohynek, Caterina Rizzo, Margarita Riera-Montes
Published in: Vaccine, 39/29, 2021, Page(s) 3964-3973, ISSN 0264-410X
Publisher: Elsevier BV
DOI: 10.1016/j.vaccine.2021.05.059

Using Point of Care Testing to estimate influenza vaccine effectiveness in the English primary care sentinel surveillance network

Author(s): Simon de Lusignan, Uy Hoang, Harshana Liyanage, Manasa Tripathy, Julian Sherlock, Mark Joy, Filipa Ferreira, Javier Diez-Domingo, Tristan Clark
Published in: PLOS ONE, 16/3, 2021, Page(s) e0248123, ISSN 1932-6203
Publisher: Public Library of Science
DOI: 10.1371/journal.pone.0248123

Investigating the procurement system for understanding seasonal influenza vaccine brand availability in Europe

Author(s): Anke L. Stuurman, Caterina Rizzo, Mendel Haag
Published in: PLOS ONE, 16/4, 2021, Page(s) e0248943, ISSN 1932-6203
Publisher: Public Library of Science
DOI: 10.1371/journal.pone.0248943

Vaccine effectiveness against laboratory-confirmed influenza in Europe – Results from the DRIVE network during season 2018/19

Author(s): Anke L. Stuurman, Kaatje Bollaerts, Maria Alexandridou, Jorne Biccler, Javier Díez Domingo, Hanna Nohynek, Caterina Rizzo, Topi Turunen, Margarita Riera-Montes
Published in: Vaccine, 38/41, 2020, Page(s) 6455-6463, ISSN 0264-410X
Publisher: Elsevier BV
DOI: 10.1016/j.vaccine.2020.07.063

Challenges and Adaptation of a European Influenza Vaccine Effectiveness Study Platform in Response to the COVID-19 Emergence: Experience from the DRIVE Project

Author(s): Antonio Carmona, Cintia Muñoz-Quiles, Anke Stuurman, Alexandre Descamps, Ainara Mira-Iglesias, Laurence Torcel-Pagnon, Javier Díez-Domingo
Published in: International Journal of Environmental Research and Public Health, 18/3, 2021, Page(s) 1058, ISSN 1660-4601
Publisher: MDPI
DOI: 10.3390/ijerph18031058

Factors driving choices between types and brands of influenza vaccines in general practice in Austria, Italy, Spain and the UK

Author(s): Anke L. Stuurman, Sara Ciampini, Alfredo Vannacci, Antonino Bella, Caterina Rizzo, Cintia Muñoz-Quiles, Elisabetta Pandolfi, Harshana Liyanage, Mendel Haag, Monika Redlberger-Fritz, Roberto Bonaiuti, Philippe Beutels
Published in: PLOS ONE, 16/6, 2021, Page(s) e0252836, ISSN 1932-6203
Publisher: Public Library of Science
DOI: 10.1371/journal.pone.0252836

Effectiveness of 2 Influenza Vaccines in Nationwide Cohorts of Finnish 2-Year-Old Children in the Seasons 2015–2016 Through 2017–2018

Author(s): Ulrike Baum, Sangita Kulathinal, Kari Auranen, Hanna Nohynek
Published in: Clinical Infectious Diseases, 2020, ISSN 1058-4838
Publisher: University of Chicago Press
DOI: 10.1093/cid/ciaa050

Influenza Vaccination in Italian Healthcare Workers (2018–2019 Season): Strengths and Weaknesses. Results of a Cohort Study in Two Large Italian Hospitals

Author(s): Donatella Panatto, Piero Luigi Lai, Stefano Mosca, Elvina Lecini, Andrea Orsi, Alessio Signori, Silvana Castaldi, Elena Pariani, Laura Pellegrinelli, Cristina Galli, Giovanni Anselmi, Giancarlo Icardi
Published in: Vaccines, 8/1, 2020, Page(s) 119, ISSN 2076-393X
Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/vaccines8010119

Integrating molecular point-of-care testing for influenza into primary care: a mixed-methods feasibility study

Author(s): Simon de Lusignan, Uy Hoang, Harshana Liyanage, Manasa Tripathy, Ivelina Yonova, Rachel Byford, Filipa Ferreira, Javier Diez-Domingo, Tristan Clark
Published in: British Journal of General Practice, 2020, Page(s) bjgp20X710897, ISSN 0960-1643
Publisher: Royal College of General Practitioners
DOI: 10.3399/bjgp20x710897

Guidance for the governance of public-private collaborations in vaccine post-marketing settings in Europe

Author(s): Laurence Torcel-Pagnon, Vincent Bauchau, Patrick Mahy, Myint Tin Tin Htar, Marianne van der Sande, Cédric Mahé, Tyra Grove Krause, Anne Charrat, François Simondon, Xavier Kurz
Published in: Vaccine, 37/25, 2019, Page(s) 3278-3289, ISSN 0264-410X
Publisher: Elsevier BV
DOI: 10.1016/j.vaccine.2019.04.073

Moderate influenza vaccine effectiveness against A(H1N1)pdm09 virus, and low effectiveness against A(H3N2) subtype, 2018/19 season in Italy

Author(s): Stefania Bellino, Antonino Bella, Simona Puzelli, Angela Di Martino, Marzia Facchini, Ornella Punzo, Patrizio Pezzotti, Maria Rita Castrucci, the InfluNet Study Group
Published in: Expert Review of Vaccines, 18/11, 2019, Page(s) 1201-1209, ISSN 1476-0584
Publisher: Future Drugs Ltd.
DOI: 10.1080/14760584.2019.1688151

Moderate Vaccine Effectiveness against Severe Acute Respiratory Infection Caused by A(H1N1)pdm09 Influenza Virus and No Effectiveness against A(H3N2) Influenza Virus in the 2018/2019 Season in Italy

Author(s): Caterina Rizzo, Francesco Gesualdo, Daniela Loconsole, Elisabetta Pandolfi, Antonino Bella, Andrea Orsi, Giulia Guarona, Donatella Panatto, Giancarlo Icardi, Christian Napoli, Giovanni Battista Orsi, Ilaria Manini, Emanuele Montomoli, Ilaria Campagna, Luisa Russo, Valeria Alfonsi, Simona Puzelli, Antonino Reale, Umberto Raucci, Livia Piccioni, Carlo Concato, Marta Luisa Ciofi Degli Atti, Alberto V
Published in: Vaccines, 8/3, 2020, Page(s) 427, ISSN 2076-393X
Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/vaccines8030427

Comparison of the clinical characteristics and outcomes of hospitalized adult COVID-19 and influenza patients – a prospective observational study

Author(s): Raija Auvinen, Hanna Nohynek, Ritva Syrjänen, Jukka Ollgren, Tuija Kerttula, Jarkko Mäntylä, Niina Ikonen, Raisa Loginov, Anu Haveri, Satu Kurkela, Kirsi Skogberg
Published in: MedRxiv, 2020, ISSN 0000-0000
Publisher: Cold Spring Harbor Laboratory
DOI: 10.1101/2020.06.29.20140632