CORDIS provides links to public deliverables and publications of HORIZON projects.
Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .
Deliverables
A specific website for the project as described in task 73 will be developed A document including screenshots and the link to the website will be generated
Halfway through the project an assessment of the degree of fulfilment of the objectives of the project will be carried out and reported in this deliverable
Report on the psychosocial impact (opens in new window)A report including the assessment of the social impacts will be elaborated
Position paper in One health area (opens in new window)Paper for policy makers and other stakeholders in the area on One health. The position paper will include recommendations for the area based in the experience of RBDCOV project.
Report on the participant's centric design protocol for RBDCOV (opens in new window)Description of the main points that have been considered and discussed during the preparation of the protocol
Notification of first patient treated in children and adolescents clinical trial (opens in new window)Report on a meeting with the VACCELERATE project, including concrete plan for collaboration (opens in new window)
Upon availability of clinical trial data that would allow further evaluation of the developed vaccine candidates in Phase II clinical trials RBDCOV will organise a meeting with the VACCELERATE project InfoVaccelerateEU to present their findings and seek advice on how to best make use of existing clinical trial infrastructure developed in the VACCELERATE project VaccelerateEU to accelerate further clinical development of the vaccine candidates
Final Business plan for RBDCOV (opens in new window)A document with the final business plan will be focused on the strategy for commercialisation and exploitation of the vaccines after the end of the project. The document will also include the business plan for any other commercial result of the project.
Regulatory strategy report (opens in new window)The regulatory report will define the regulatory pathway and milestones for the optimal development of the vaccine including also CMC preclinical and clinical aspects and considering EMA Fast track procedures
Report on communication and dissemination activities (opens in new window)A detailed list of dissemination activities carried out halfway through the project with assessment of their impact the degree of compliance with the plan and a description of foreseen dissemination activities until the end of the projectThe report will be updated in month 24 and 30
Children and adolescents initiation package (opens in new window)The deliverable will be submitted before the enrolment of the first participant and will include the registration number of the clinical study, final version of the study protocol (approved by regulators and ethical committees) and the copies of the document that demonstrate the approval of the trial in the correspondent sites
Children and adolescents Mid-term recruitment report (opens in new window)A report including the number of participants included at each clinical site until the end of month 5 of the clinical trial where the achievement of the 50% participants is expected
Data Management Plan for RBDCOV project (opens in new window)A data management plan addressing all the aspects inlcuded in the template for data management plans avaliable for Horizon Europe projects will be submitted as deliverable This DMP will be aligned with the draft included in the submission of the Grant Agreement and will be updated accordingly during the project duration
Plan for the Exploitation and Dissemination of Results (PEDR) (opens in new window)This document will describe in detail the project communication dissemination and exploitation strategy in all of its components objectives audiences channels actions results IP management and tools
Notification of first patient treated in Variants' clinical trial (opens in new window)Notification of first patient treated in Variants clinical trial
Report on the early engagement with the European Medical Agency (opens in new window)A brief report on a consultation with the European Medical Agency EMA to ensure that regulatory aspects for the clinical development and evaluation of the candidate compounds are properly addressed and embedded in the study design Scientific advice and protocol assistance European Medicines Agency europaeu Requesting scientific advice or protocol assistance from EMA European Medicines Agency europaeu
Report on the status of posting results of the vaccine in children (opens in new window)Summary of the posting results in the applicable registry.
Mid-term recruitment report of the variant vaccine (opens in new window)A report including the number of participants included at each clinical site until the end of month 5 of the clinical trial where the achievement of the 50 participants is expected
MA&P strategy report (opens in new window)The market access and pricing strategy for the vaccines developed by HIPRA will be described in this report including the potential risks and markets for the commercialisation with a clear OH strategy
Quality assurance guidelines and procedures (opens in new window)A set of quality assurance principles
Report on the status of posting results of the variant vaccine (opens in new window)A summary of the posting results in the applicable registry
Biological sample logs and database with clinical information (opens in new window)This deliverable will account for the generation of a comprehensive database including sample information and clinical information according to the data management plan.
Toolbox with the information documents co-developed with the CAB (opens in new window)Including info sheets, informed consent, etc.
Target communication tools (opens in new window)How to communicate complex information into a laymans language Infographics among other tools will be summarised in the deliverable
Final assessment of the project (opens in new window)At the end of the project, a final assessment of the degree of fulfilment of the objectives of the project.
Includes details around database workflows external vendors requirements for reconciliations and details surrounding planned formal analyses including final database lock
Intellectual Property Rights
Application/Publication number:
EU
018704530
Date:
2022-05-17
Applicant(s):
LABORATORIOS HIPRA SA
Application/Publication number:
EU
018704520
Date:
2022-05-17
Applicant(s):
LABORATORIOS HIPRA SA
Application/Publication number:
20
22060941
Date:
2022-04-25
Applicant(s):
HIPRA SCIENTIFIC SL
Application/Publication number:
20
22060941
Date:
2022-04-25
Applicant(s):
LABORATORIOS HIPRA SA
Application/Publication number:
20
22060942
Date:
2022-04-25
Applicant(s):
LABORATORIOS HIPRA SA
Application/Publication number:
20
22060942
Date:
2022-04-25
Applicant(s):
HIPRA SCIENTIFIC SL
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