The dose-confirming trial will evaluate the safety and effectiveness (immunogenicity) of different formulations of the CIC and influenza vaccine candidates in adults aged 50 through 80.

"We're encouraged by the initiation of this trial given the positive results shared earlier this year from our Phase 1/2 trial, the first of its kind to evaluate a combined COVID-19 and influenza vaccine," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We believe that like influenza, COVID-19 will also be seasonal moving forward, and that there is room in the market for new alternatives to provide better protection against the impact of influenza, particularly in older adults, and to explore the potential to combine this with protection from COVID."

The randomized, observer-blinded trial will assess a combination of Novavax' recombinant protein-based COVID-19 vaccine (NVX-CoV2373), quadrivalent influenza vaccine candidate, and patented saponin-based Matrix-M™ adjuvant. Primary and secondary objectives of the study are to assess the safety, tolerability, and immune responses to various formulations of the CIC and influenza vaccine candidates. The Phase 2 dose-confirmation trial will be conducted in two parts and seek to enroll a total of approximately 2,300 participants across multiple sites located in Australia and New Zealand.

Initial results of the trial are expected mid-year 2023. These data will inform the Phase 3 trials for both influenza stand-alone and COVID-19-influenza combination candidates.