Common use of Regulatory Considerations Clause in Contracts

Regulatory Considerations. The study will be conducted according to the ethical principles set forth in the Declaration of Helsinki, ICH GCP, and local regulatory requirements as applicable. The study site(s) should have recruitment and retention guidelines appropriate for different age groups (e.g., infants, adolescents, adults). The protocol and informed consent form will be reviewed and approved by an IRB/IEC prior to any protocol-specified procedures being conducted. The Investigator is responsible for ensuring that the protocol is reviewed by an IRB/IEC with the appropriate composition (per clinical study site guidelines). The Investigator will inform the IRB/IEC as to the progress of the study at applicable intervals as defined by IRB/IEC policy. There are potential known and unknown risks associated with vaccination. With any vaccine, including licensed ones, there is a rare risk of anaphylaxis which can be fatal. Participants will therefore be observed in the clinic for at least 10 minutes post-vaccination. Vaccination may also cause Guillain-Barré syndrome causing severe weakness, which may also be fatal. Intramuscular injection of influenza vaccines frequently causes the local and systemic signs and symptoms that are being collected as adverse events. These will be solicited from the participant to ensure they are nor occurring more frequently or are more severe than expected. With any new treatment there is always a possibility of an unexpected adverse events. Pausing and holding rules have been defined for the study (see Section 2.3) and the DMC will perform a review of safety data if one of these is met. There are also routinely scheduled reviews of safety and efficacy data throughout the study. To maintain confidentiality, participant identification numbers will be used to identify laboratory samples, source documents, eCRF, study reports etc. All study records will be maintained in a secured location. Clinical information will not be released without written permission from the participant except as necessary for monitoring or auditing of the study by the Sponsor or its designee or applicable regulatory authorities. After the study has been unblinded, the participant should be informed by the Investigator whether they received MVA-NP+M1 or placebo.