Safety and Immunogenicity Summary Sample Clauses

Safety and Immunogenicity Summary. The vaccine has been shown to have a good safety profile with no vaccine related serious adverse events (SAEs). A dose dependent increase in adverse events was observed, and a dose of 1.5 x108 plaque forming units (pfu) was found to be the optimal balance between immunogenicity and reactogenicity across age groups [11]. There was no apparent difference between the vaccine manufactured in CEF and using AGE1.CR.pIX®. The vaccine also had a good safety profile when co-administered with the standard seasonal influenza vaccine. Vaccination with MVA-NP+M1 results in a rapid increase in influenza-specific cross-reactive interferon gamma (IFN-γ)-secreting effector T-cells (determined by enzyme-linked immunosorbent spot (ELISpot) assay) across age groups which are maintained at protective levels over the course of a year [11]. In the older age groups, MVA-NP+M1 can boost pre-existing levels of influenza-specific T-cells and maintain them for up to at least 6 months post-vaccination [19]. The immunogenicity of MVA-NP+M1 in older adults (aged 50+) receiving a dose of 1.5 x108 pfu (Study FLU001) is shown in Figure 1-1. MVA-NP+M1 in combination with licensed inactivated influenza vaccine induced influenza-specific T-cells and in addition, increase the magnitude and breadth of the antibody response induced by the inactivated influenza vaccine [20]. There was no statistically significant difference between T-cell responses when data from participants receiving MVA-NP+M1 manufactured using AGE1.CR.pIX® was compared with historical data from MVA-NP+M1 manufactured in CEF (FLU005), as shown in Figure 1-2. Figure 1-1 Immunogenicity of MVA-NP+M1 in Older Adults (FLU001) Weeks Post-vaccination Abbreviations: PBMC=peripheral blood mononuclear cells; SFU=spot forming units; W=weeks Figure 1-2 Area under the Curve Responses for Participants Vaccinated using MVA-NP+M1 (1.5 × 108 pfu) Manufactured on AGE1.CR.pIX® and Chicken Embryo Fibroblasts n s A U C 4 0 0 0 0 0 A G E 1 . C R . p IX C E F Abbreviations: AUC=area under the curve; CEF=chicken embryo fibroblasts Individual and median values are shown Comparison performed using the Xxxx-Xxxxxxx test on data from FLU008 compared to historical data from Xxxxxxxx et al. (FLU005) [21]
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Related to Safety and Immunogenicity Summary

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  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • SAFETY AND ACCIDENT PREVENTION In performing work under this Contract on State premises, Contractor shall conform to any specific safety requirements contained in the Contract or as required by law or regulation. Contractor shall take any additional precautions as the State may reasonably require for safety and accident prevention purposes. Any violation of such rules and requirements, unless promptly corrected, shall be grounds for termination of this Contract in accordance with the default provisions hereof.

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Material Safety Data Sheet Seller shall provide to Buyer with each delivery any Material Safety Data Sheet applicable to the work in conformance with and containing such information as required by the Occupational Safety and Health Act of 1970 and regulations promulgated thereunder or its State approved counterpart.

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  • Comprehensive Assessment an initial and ongoing part of the member-centered planning process employed by the interdisciplinary team (IDT) to identify the member’s outcomes and the services and supports needed to help support those outcomes. It includes an ongoing process of using the knowledge and expertise of the member and caregivers to collect information about:

  • Trials The Ship shall run the following test and trials:

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