Novavax, Inc. announced the initiation of a Phase 2 trial for its COVID-19-Influenza Combination (CIC) and influenza stand-alone vaccine candidates. 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. 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.