Common use of Rationale for Study Clause in Contracts

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.