Development/production of universal influenza vaccines

将按照现行的良好生产规范（cGMP）生产对多种病毒株具有免疫力的流感疫苗，用于人体临床试验，并发布用于健康人类志愿者的人体临床试验。这些疫苗可能具有广泛的免疫力，即在数年内对多种毒株产生“通用流感疫苗”，而季节性产品仅对单一季节有用。如果这些试验在人体试验中证明了该疫苗的安全性和免疫原性，则可能会在更大规模的（2期）试验中进行进一步评估，这将需要大规模生产临床试验材料（CTM）。这种疫苗在多个季节都有效，需要长期的临床研究和监测不同季节菌株的有效性。

Influenza vaccines conferring immunity against multiple strains of virus will be manufactured for human clinical trials in compliance with current Good Manufacturing Practices (cGMP) and released for use in human clinical trials in healthy human volunteers. These vaccines may confer broad immunity a "universal influenza vaccine" over a period of several years against multiple strains in contrast to seasonal products that are only useful for a single season. If these trials demonstrate safety and immunogenicity of this vaccine in human trials, further evaluation may take place in larger (Phase 2) trials which will necessitate production of the clinical trial materials (CTM) at large scale. Such vaccines would be effective over multiple seasons and would require lengthy clinical study and monitoring for effectiveness across strains that vary from season to season.