Provision Language
7. Clinical Studies
For the purposes of this section, where an LMIC Manufacturer will be undertaking clinical studies, and provided such clinical studies have been funded by CEPI under this Agreement, Awardee will obligate the relevant LMIC Manufacturer to comply with the obligations applicable to Awardee, mutatis mutandis.
7.1 Clinical Studies. if any work package includes research involving human subjects, such activities must comply with applicable laws, the requirements of any relevant regulatory agency and with CEPI’s Clinical Trials Policy.
7.2 Clinical Data. where applicable, the data arising in the conduct of a clinical trial will be collected in a way that ensures that each subject, prior to enrolment and in accordance with all applicable laws and regulations, including the EU’s General Data Protection Regulation (GDPR), provides informed consent to allow:
a. direct access to her or his medical records;
b. the processing of data relating to her or him and to the movement of that data to other countries, including countries outside of the European Economic Area;
c. the transfer of such data to awardee;
d. the transfer of anonymised data to CEPI;
e. the collection and use of clinical study data (duly anonymised and, at CEPI’s request, blinded) in accordance with and for the purposes indicated in Clause 13;
f. the collection and use of biological samples and the use of data (duly anonymised and, at CEPI’s request, blinded) derived from such samples by CEPI or its designated Assessors in accordance with and for the purposes indicated in Clause 14; and
g. the use of such data for the purpose of obtaining approval from applicable regulatory agencies.
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7.4 The Awardee will:
a. be the sponsor of any clinical study, or ensure that a sub-awardee acting as local sponsor, fulfils all sponsor obligations as detailed below;
b. be responsible for obtaining and maintaining all regulatory approvals (including ethical committee approvals) necessary or reasonably useful for the conduct of the clinical trial and appropriate clinical trial insurance cover;
c. publish details of any clinical study in a publicly accessible clinical study register, where patient privacy is upheld, as required under law and, as applicable, prior to the commencement of patient recruitment for such clinical study;
d. ensure that any informed consent form permits the use of project results described in these T&Cs and in the IPDP;
e. establish a data safety monitoring board (DSMB);
f. notify the JMAG in writing immediately following any safety issues or similar events;
g. verify that the clinical study data are complete and include all completed case report forms and all other clinical study documentation required to be in the possession of a clinical trial sponsor by applicable law;
h. subject to the confidentiality provisions contained in clause 24.4, permit a CEPI representative or nominee (except for any matters that should remain blinded to CEPI in the interests of the integrity of the clinical study and except for closed sessions) to: a. attend meetings of the DSMB for the clinical study as an observer (either in person or by electronic means); and b. receive all papers that a member of the TSC (as defined in Clause 7.5a) or DSMB would be entitled to receive.
7.5 In order to support the clinical studies funded by CEPI (whether in whole or in part), the awardee:
a. will establish a trial steering committee (TSC) or any other appropriate clinical oversight setting, as agreed between the Parties; and
b. shall use commercially reasonable endeavours to adhere to any further requirements under this Clause 7.5, as agreed between the Parties. Such requirements may be similar to and may include but not be limited to those requirements outlined under Clause 7.4 (f) and 7.4 (h) above.
13. Dissemination and Publication of Project Data
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13.5 Clinical Study Data. CEPI’s clinical trials policy requires that clinical data and results (including negative results) must be disclosed publicly in as close to real time as possible. Accordingly, such data and results must be shared through an easily discoverable public route (website or system) that includes a metadata description, where patient privacy is upheld, and the system follows a request- for- information approach (where requests are fulfilled subject to an independent review and approval step). Clinical study data will be submitted for publication within [***] after each final study report or report submitted to CEPI unless Awardee has reasons for a delay of the publication of the clinical study data and said delay is agreed in writing with CEPI. The Clinical Trial ID or registry identifier code/number shall be included in all publications of clinical trials. Notwithstanding the foregoing, the terms of this Clause 13.5 shall not be mandatory with respect to clinical data and results arising from any Awardee-Funded Study.
Annex C. Integrated Product Development Plan (IPDP)
1. Project description
1.1. Introduction and background
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VLA1553 / brand name IXCHIQ has completed all necessary Phase 3 clinical studies to obtain FDA approval under the accelerated approval pathway in adults. It is Valneva’s objective to improve and extend the future use of Valneva’s chikungunya vaccine. Planned studies aim at generating evidence for:
- Data to facilitate and improve the implementation of the vaccine: Such as, antibody persistence long-term safety, safety and immunogenicity in special populations (e.g. pregnant women, immunocompromised; Phase 3 studies), local registration studies as well as data to strengthen the case of effectiveness of the vaccine against chikungunya virus in endemic areas (Phase 4 studies).
- Paediatric population – a vulnerable and therefore important target population for immunization, since in case of an outbreak they may lack immunity from previous outbreaks and the majority of use of the chikungunya vaccine in the paediatric population is expected to occur in LMIC countries (Dose finding Phase 2 and Phase 3 studies).
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3. Quality management strategy
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Clinical conduct: Valneva performs its clinical studies in compliance with ICH and its applicable regulation. Adherence of the involved parties is being assured applying different measures: […]