The randomised, observer-blinded, dose-confirming trial has been designed for assessing the effectiveness (immunogenicity) and safety of various formulations of the CIC and influenza vaccine candidates in participants aged 50 to 80 years.
The combination of the company’s recombinant protein-based Covid-19 vaccine, NVX-CoV2373; quadrivalent influenza vaccine candidate; and saponin-based Matrix-M adjuvant will be evaluated in the trial.
Tolerability, immune response, and safety of different formulations of the CIC and influenza vaccine candidates will be the study’s primary and secondary objectives.
Novavax stated that the dose-confirmation Phase II trial will enrol nearly 2,300 subjects across many sites in New Zealand and Australia.
It is planned to be conducted in two parts, with initial results anticipated in the middle of this year.
Novavax president and CEO Stanley Erck said: “We’re encouraged by the initiation of this trial given the positive results shared earlier this year from our Phase I/II trial, the first of its kind to evaluate a combined Covid-19 and influenza vaccine.
“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 company stated that the data from the Phase II trial will inform the Phase III trials for both influenza-alone as well as the combination of Covid-19-influenza candidates.