Rationale for Study Sample Clauses

Rationale for Study. Vaccination remains the most cost-effective strategy available to combat influenza. Current influenza vaccines work by inducing strain-specific antibodies against the highly polymorphic surface proteins of the influenza virus. The need for constant redesign and remanufacture increases the vaccine’s cost, places limitations on supply and critically delays vaccine production when new strains arise. There is therefore a major demand for improved vaccination strategies that can provide protection against a broad spectrum of virus strains. Previous studies have demonstrated the safety of MVA-NP+M1 across different age groups, including older adults and in combination with seasonal influenza vaccine; the immunogenicity of MVA-NP+M1 in older adults given alone and in combination with licensed inactivated seasonal influenza vaccine; and the effect of MVA-NP+M1 in limiting the severity of influenza illness in adults. This study will therefore investigate the immunogenicity and efficacy in terms of viral and symptom endpoints in a large number of healthy adults aged 18 and over when given as an adjunct to standard QIV. This MVA-NP+M1, produced using the novel immortalised duck retinal cell line AGE1.CR.pIX®, also addresses the scalability issues of CEF manufactured vaccines.
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Rationale for Study. This study is being conducted as an FDA post marketing commitment to the approved New Drug Application for TPOXX. SIGA is required to conduct a study to determine the pharmacokinetic (PK) profile of TPOXX in subjects with a body weight greater than 120 kilograms (>120 kg) to determine if a change in dosing regimen would be needed in these patients.
Sample 1

Related to Rationale for Study

  • Time for Submission Except as specified below, any claim by Contractor for a change in the Contract Time or the Material Completion and Occupancy Date shall be made within fourteen days of the day on which the Contractor becomes aware of the event on which the claim is based or, if the Contract Documents specify a shorter or longer period with respect to such event, within the period specified by the Contract Documents.

  • Criteria for Selection a. The Sabbatical Selection Committee shall use four (4) criteria for selection of academic employees to receive sabbaticals. These are: the merit of the sabbatical project, the applicant’s current and previous contributions to the College community, the proposal’s relevancy to the College’s Strategic Plan and whether or not the applicant has had a previous sabbatical. In instances where these criteria are equal, seniority shall be the determining factor.

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  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Presentation for Scaling Purchaser shall present products so that they may be Scaled in an eco- nomical and safe manner. If prior to Scaling, Included Timber is to be mixed with other timber, Purchaser shall, prior to mixing, provide for distinguishing, by means ap- proved by Forest Service, each product included in this contract. Trees or pieces presented for Scaling that have not been bucked to separate material meeting minimum piece standards from material not meeting minimum piece standards due to diameter, shall be Scaled as though such bucking had been done. Deductions made for rot, check, or other defects re- sulting from abnormal delay in Scaling caused by Pur- chaser shall be recorded separately and charged to Xxx- ber Sale Account under B3.47. Any timber that has been removed from Sale Area during the period of this contract, but remains unscaled after Termination Date, shall be Scaled at the earliest rea- sonable date.

  • Ineligible for Sick Leave Employees are not eligible for sick leave with pay for any period during which they are on leave of absence without pay, under suspension, on strike, on layoff, or locked out.

  • Requests For Samples By Authorized Users Requests for samples by Authorized Users require the consent of the Contractor. Where Contractor refuses to furnish a sample, Authorized User may, in its sole discretion, make a determination on the performance capability of the Product or on the issue in question. BID EVALUATION

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Time Off for Selection Procedures A regular, limited-term or probationary employee shall be entitled to necessary time off with pay to participate in tests of fitness, examinations and interviews required by the Chief Human Resources Officer during working hours for the purpose of determining eligibility for movement to another class in the County service or transfer from one agency/department to another.

  • Criteria for Promotion 24.04.01 For evaluating each application for promotion, the following general criteria shall apply:

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